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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02923193
Registration number
NCT02923193
Ethics application status
Date submitted
28/09/2016
Date registered
4/10/2016
Date last updated
20/12/2023
Titles & IDs
Public title
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
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Scientific title
Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
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Secondary ID [1]
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CP 60892
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Shockwave Lithoplasty® Peripheral Lithoplasty System
Treatment: Drugs - Medtronic IN.PACT (DCB)
Experimental: Lithoplasty System followed by DCB - Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty
Active Comparator: Medtronic IN.PACT (DCB) - Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Treatment: Devices: Shockwave Lithoplasty® Peripheral Lithoplasty System
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
Treatment: Drugs: Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Procedural Success
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Assessment method [1]
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Procedural success is defined as residual stenosis =30% without flow-limiting dissection (= grade D) prior to DCB or stenting by angiographic core lab.
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Timepoint [1]
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Peri-Procedural, approximately 2 hours
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Secondary outcome [1]
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Number of Participants With Major Adverse Events (MAEs)
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Assessment method [1]
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Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
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Timepoint [1]
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30 days
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Secondary outcome [2]
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0
Clinical Success ABI
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Assessment method [2]
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Defined as ankle-brachial index ABI reported at 30 days as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Clinical Success Quality of Life
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Assessment method [3]
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Defined by Quality of Life assessed by EQ5D questionnaire reported at 30 days as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied. It ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status."
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Timepoint [3]
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30 days
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Secondary outcome [4]
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Clinical Success Rutherford Category
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Assessment method [4]
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Defined as Rutherford Category reported at 30 days as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
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Timepoint [4]
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30 days
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Secondary outcome [5]
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Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
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Assessment method [5]
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Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
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Timepoint [5]
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30 days
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Secondary outcome [6]
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Number of Participants With Major Adverse Events (MAEs)
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Assessment method [6]
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Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
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Timepoint [6]
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0
6 months
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Secondary outcome [7]
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Clinical Success Rutherford Category
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Assessment method [7]
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Defined as Rutherford Category reported at 6 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
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Assessment method [8]
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Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
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Timepoint [8]
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6 months
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Secondary outcome [9]
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Clinical Success ABI
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Assessment method [9]
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Defined as ankle-brachial index ABI reported at 6 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
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Timepoint [9]
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6 months
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Secondary outcome [10]
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Clinical Success Quality of Life
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Assessment method [10]
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Defined by Quality of Life assessed by EQ5D questionnaire reported at 6 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Number of Participants With Primary Patency
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Assessment method [11]
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Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
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Timepoint [11]
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12 months
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Secondary outcome [12]
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Number of Participants With Major Adverse Events (MAEs)
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Assessment method [12]
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Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
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Timepoint [12]
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12 months
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Secondary outcome [13]
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Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
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Assessment method [13]
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Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
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Timepoint [13]
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12 months
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Secondary outcome [14]
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Clinical Success ABI
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Assessment method [14]
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Defined as ankle-brachial index ABI reported at 12 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Clinical Success Rutherford Category
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Assessment method [15]
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Defined as Rutherford Category reported at 12 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
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Timepoint [15]
0
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12 months
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Secondary outcome [16]
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Clinical Success Quality of Life
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Assessment method [16]
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Defined by Quality of Life assessed by EQ5D questionnaire reported at 12 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Number of Participants With Primary Patency
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Assessment method [17]
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Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
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Timepoint [17]
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24 months
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Secondary outcome [18]
0
0
Number of Participants With Major Adverse Events (MAEs)
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Assessment method [18]
0
0
Need for emergency surgical revascularization of target limb
Unplanned target limb major amputation (above the ankle)
Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
Perforations that require an intervention, including bail-out stenting
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Timepoint [18]
0
0
24 months
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Secondary outcome [19]
0
0
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
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Assessment method [19]
0
0
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
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Timepoint [19]
0
0
24 months
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Secondary outcome [20]
0
0
Clinical Success ABI
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Assessment method [20]
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Defined as ankle-brachial index ABI reported at 24 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
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Timepoint [20]
0
0
24 months
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Secondary outcome [21]
0
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Clinical Success Rutherford Category
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Assessment method [21]
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Defined as Rutherford Category reported at 24 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
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Timepoint [21]
0
0
24 months
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Secondary outcome [22]
0
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Clinical Success Quality of Life
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Assessment method [22]
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Defined by Quality of Life assessed by EQ5D questionnaire reported at 24 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
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Timepoint [22]
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24 months
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Eligibility
Key inclusion criteria
Randomized Study Arm Eligibility Criteria
General Inclusion Criteria
1. Subject is able and willing to comply with all assessments in the study.
2. Subject or subject's legal representative have been informed of the nature of the
study, agrees to participate and has signed the approved consent form.
3. Age of subject is greater than or equal to 18.
4. Rutherford Clinical Category 2, 3, or 4 of the target limb.
5. Estimated life expectancy >1 year.
6. Subject is a suitable candidate for angiography and endovascular intervention in the
opinion of the investigator or per hospital guideline.
7. Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with
standard balloon pre-dilatation.
Angiographic Inclusion Criteria
8. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or
popliteal artery (popliteal artery extends to and ends proximal to the ostium of the
anterior tibial artery).
9. Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
10. Target lesion is =70% stenosis by investigator via visual estimate.
11. Target lesion length is =180mm for lesions 70-99% stenosed. Target lesion can be all
or part of the 180mm treated zone.
12. Chronic total occlusion, lesion length is =100mm of the total =180 mm target lesion.
13. Subject has at least one patent tibial vessel on the target leg with runoff to the
foot, defined as no stenosis >50%.
14. Calcification is at least moderate defined as presence of fluoroscopic evidence of
calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of
the lesion if lesion is =50mm in length; or extending for minimum of 20mm if lesion is
<50mm in length.
General
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Rutherford Clinical Category 0, 1, 5 and 6.
2. Subject has active infection requiring antibiotic therapy.
3. Planned target limb major amputation (above the ankle).
4. History of prior endovascular or surgical procedure on the index limb within the past
30 days or planned within 30 days of the index procedure.
5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with
platelet count less than 100,000/microliter.
6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
7. Subject has known allergy to contrast agents or medications used to perform
endovascular intervention that cannot be adequately pre-treated.
8. Subject has known allergy to urethane, nylon, or silicone.
9. Myocardial infarction within 60 days prior to enrollment.
10. History of stroke within 60 days prior to enrollment.
11. History of thrombolytic therapy within two weeks of enrollment.
12. Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL
or >220 umol/L, or on dialysis.
13. Subject is pregnant or nursing.
14. Subject is participating in another research study involving an investigational agent
(pharmaceutical, biologic, or medical device) that has not reached the primary
endpoint.
15. Subject has other medical, social or psychological problems that, in the opinion of
the investigator, preclude them from receiving this treatment, and the procedures and
evaluations pre- and post-treatment.
16. The use of specialty balloons, re-entry or atherectomy devices.
Angiographic Exclusion Criteria
17. In-stent restenosis within 10mm of the target zone.
18. Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the
anterior tibial artery.
19. Evidence of aneurysm or thrombus in target vessel.
20. No calcium or mild calcium in the target lesion.
21. Target lesion within native or synthetic vessel grafts.
22. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before
target treatment zone (e.g. iliac or common femoral) not successfully treated.
23. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to
target site at the time of the index procedure.
24. Failure to successfully cross the guidewire across the target lesion; successful
crossing defined as tip of the guidewire distal to the target lesion in the absence of
flow limiting dissections or perforations.
Subjects who do not meet the inclusion/exclusion criteria for the randomized study may
satisfy the eligibility criteria for the observational study.
Observational Study Eligibility Criteria
Inclusion Criteria
1. Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty®
System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and
infra-popliteal arteries.
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5,
or 6 of the target limb.
3. Age of subject is > 18.
4. Subject or subject's legal representative have been informed of the nature of the
study, agrees to participate, and has signed the approved study consent form.
5. Calcification is at least moderate, defined as presence of fluoroscopic evidence of
calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of
the lesion if lesion is =50mm in length; or extending for minimum of 20mm if lesion is
<50mm in length.
Exclusion Criteria
1. Subjects with any medical condition that would make him/her an inappropriate candidate
for treatment with Shockwave Medical Peripheral Lithoplasty® System as per
Instructions for Use (IFU) or investigator's opinion.
2. Subject is already enrolled in other investigational (interventional) studies that
would interfere with study endpoints.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/06/2022
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Sample size
Target
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Accrual to date
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Final
306
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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0
0
United States of America
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0
Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Iowa
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Maine
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Michigan
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New York
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North Carolina
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Texas
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West Virginia
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Austria
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Graz
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Austria
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Vienna
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Germany
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0
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Arnsberg
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0
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Germany
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0
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Bad Krozingen
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0
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Germany
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0
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Berlin
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0
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Germany
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Bonn
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0
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Germany
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0
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Bruchsal
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Munster
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Germany
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Mülheim
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Germany
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Rosenheim
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New Zealand
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shockwave Medical, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind,
randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard
balloon angioplasty used in combination with DCB to treat moderate and severely calcified
femoropopliteal arteries. Assuming that roughly 15% of the subjects will be
lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in
the study at up to 60 sites in Europe, the United States and New Zealand.
In addition to the randomized study, an observational study of subjects who do not meet the
inclusion/exclusion criteria for the randomized study will be conducted. The objective of the
observational study is to assess the real-world acute performance of the Shockwave Medical
Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.
The observational study is a prospective, multi-center, single arm observational study for
subjects who do not meet the inclusion/exclusion criteria of the randomized study.
A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study.
Once enrollment in the randomized portion of the study is complete, subjects may continue to
be enrolled in the observational study provided they meet OS eligibility criteria.
Results for the observational study will be reported in a separate record under NCT05881421.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02923193
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Contacts
Principal investigator
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Gunnar Tepe, MD
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RoMed Klinikum Rosenheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02923193
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