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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/NCT02071108
Registration number
NCT02071108
Ethics application status
Date submitted
22/02/2014
Date registered
25/02/2014
Date last updated
24/03/2017
Titles & IDs
Public title
Safety and Performance Study of the Shockwave Lithoplasty System
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Scientific title
Safety and Performance Study of the Shockwave Lithoplasty System
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Secondary ID [1]
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TD 0083
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Universal Trial Number (UTN)
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Trial acronym
DISRUPT-PAD
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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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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 System
Experimental: Lithoplasty Treatment - Shockwave Lithoplasty System
Treatment: Devices: Shockwave Lithoplasty System
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Intervention code [1]
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Treatment: Devices
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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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Composite of New-onset Major Adverse Events (MAE)
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Assessment method [1]
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Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.
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Timepoint [1]
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30 days
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Primary outcome [2]
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Procedural Success:
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Assessment method [2]
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The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.
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Timepoint [2]
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Day of Procedure
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Secondary outcome [1]
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Device Success
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Assessment method [1]
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The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.
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Timepoint [1]
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Day of Procedure
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Secondary outcome [2]
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Clinical Success:
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Assessment method [2]
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The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.
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Timepoint [2]
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Day of Procedure
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Secondary outcome [3]
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Technical Success:
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Assessment method [3]
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The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.
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Timepoint [3]
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Day of Procedure
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Secondary outcome [4]
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Freedom From Major Adverse Events
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Assessment method [4]
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Freedom from Major Adverse Events at 30 days.
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Timepoint [4]
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30 days
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Secondary outcome [5]
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Freedom From Target Lesion Revascularization (TLR)
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Assessment method [5]
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Freedom from Target Lesion Revascularization (TLR) at 30 days
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Timepoint [5]
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30 days
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Secondary outcome [6]
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Patency
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Assessment method [6]
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Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).
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Timepoint [6]
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30 days
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Secondary outcome [7]
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Ankle Brachial Index (ABI)
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Assessment method [7]
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Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
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Timepoint [7]
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Baseline and 30 days
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Secondary outcome [8]
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Rutherford Clinical Category
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Assessment method [8]
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Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.
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Timepoint [8]
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Baseline and 30 days
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Secondary outcome [9]
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Freedom From Major Adverse Events
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Assessment method [9]
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Freedom from Major Adverse Events at 6 months
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Timepoint [9]
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6 months
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Secondary outcome [10]
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Freedom From Target Lesion Revascularization (TLR)
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Assessment method [10]
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Freedom from Target Lesion Revascularization (TLR) at 6 months
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Patency
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Assessment method [11]
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Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).
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Timepoint [11]
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6 months
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Secondary outcome [12]
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Ankle Brachial Index (ABI)
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Assessment method [12]
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Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
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Timepoint [12]
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Baseline and 6 months
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Secondary outcome [13]
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Rutherford Clinical Category
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Assessment method [13]
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Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.
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Timepoint [13]
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Baseline and 6 months
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Eligibility
Key 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 >18.
4. Rutherford Clinical Category 2, 3, or 4.
5. Resting ankle-brachial index (ABI) of =0.90, or =0.75 after exercise, of the target
leg.
6. Moderate to severe calcification of target lesion(s) per pre-procedure CT scan.
(Calcification must be: 1) =180 degrees circumferential at some point in the lesion
and 2) extend =50 percent length of lesion or absolute length =20mm.)
7. Estimated life expectancy >1 year.
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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
1. Rutherford Clinical Category 5 and 6.
2. Subject has active infection in the target leg.
3. Planned major amputation of the target leg (transmetatarsal or higher).
4. In-stent restenosis within the target lesion(s).
5. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the
balloon).
6. Chronic total occlusion of the target lesion(s).
7. Target lesion(s) within native or synthetic vessel grafts.
8. Chronic total occlusion of inflow vessel.
9. Lesion in contralateral limb requiring intervention within the next 30 days.
10. History of prior endovascular or surgical procedure on the index limb within the past
30 days.
11. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract
(upstream disease) not successfully treated with plain old balloon angioplasty or
stent and without complications before target lesion(s) treatment.
12. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to
the target lesion(s) at the time of the enrollment / index procedure.
13. Subject has a known coagulopathy or has a bleeding diatheses, thrombocytopenia with
platelet count less than 100,000/microliter, or international normalized ratio >1.5.
14. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is
contraindicated.
15. Subject has known allergy to contrast agents or medications used to perform
endovascular intervention that cannot be adequately pre-treated.
16. Subject has known allergy to urethane, nylon, or silicone.
17. Myocardial infarction within 60 days prior to enrollment.
18. History of stroke within 60 days prior to enrollment.
19. History of unstable coronary artery disease or other uncontrollable comorbidity
resulting in hospitalization within the last 60 days prior to enrollment.
20. History of thrombolytic therapy within two weeks of enrollment.
21. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of
>2.5 mg/dL or >220 umol/L), or on dialysis.
22. Subject is pregnant or nursing.
23. Subject is participating in another research study involving an investigational agent
(pharmaceutical, biologic, or medical device) that has not reached the primary
endpoint.
24. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/01/2014
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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
1/03/2015
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Country [2]
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Germany
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State/province [2]
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Baden-Württemberg
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Country [3]
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New Zealand
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State/province [3]
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects
to demonstrate that the Shockwave device can safely and effectively deliver localized
shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral
arteries.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02071108
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas Zeller, MD
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Address
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Bad Krozingen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02071108
Download to PDF