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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/NCT02369848
Registration number
NCT02369848
Ethics application status
Date submitted
9/02/2015
Date registered
24/02/2015
Date last updated
18/04/2018
Titles & IDs
Public title
Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
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Scientific title
Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
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Secondary ID [1]
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TD 0232
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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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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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Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From =50% Restenosis
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Assessment method [1]
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Timepoint [1]
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12 months post-procedure
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Primary outcome [2]
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Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)
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Assessment method [2]
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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 and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization.
Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.
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Timepoint [2]
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Within 30 days following procedure
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Secondary outcome [1]
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Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants
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Assessment method [2]
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The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation.
The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive PTA 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 [3]
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Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From =50% Restenosis.
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Assessment method [3]
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From =50% Restenosis.
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Assessment method [4]
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.
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Assessment method [5]
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The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.
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Assessment method [6]
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The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Clinical Success
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Assessment method [7]
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Change in Rutherford Clinical Category at from Baseline to 6 months.
There are seven stages to consider:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Clinical Success
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Assessment method [8]
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Change in Rutherford Clinical Category from Baseline to12 months.
There are seven stages to condsider:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Clinical Success
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Assessment method [9]
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Change in Rutherford Clinical Category from Baseline to 30 days
There are seven stages to condsider:
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
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Timepoint [9]
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30 days
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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. Estimated life expectancy >1 year.
Angiographic
1. Subject is a suitable candidate for angiography and endovascular intervention in the
opinion of the investigator or per hospital guideline.
2. 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).
3. Target lesion reference vessel diameter is between 3.50mm and 7.0mm by visual
estimate.
4. Target zone is =150mm in length. Target lesion can be all or part of the 150mm zone.
5. Target lesion is =70% stenosis by investigator via visual estimate.
6. Subject has at least one patent tibial vessel on the target leg with runoff to the
ankle (not supported by collateral circulation.) Tibial vessel patency is defined as
no stenosis >50%.
7. Ability to pass the guidewire across the atherosclerotic lesion.
8. No evidence of aneurysm or acute or chronic thrombus in target vessel.
9. Calcification is at least moderate. (Presence of fluoroscopic evidence of
calcification: 1) on parallel sides of the vessel and 2) extending = 50% the length of
the lesion.)
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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. The use of chronic total occlusion (CTO) re-entry devices.
5. CTOs greater than 80 mm in length.
6. Any in-stent restenosis within the target zone.
7. Lesions within 10 mm of ostium of the SFA.
8. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the
balloon).
9. Target lesion within native or synthetic vessel grafts.
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 before
target treatment zone (e.g. iliac or common femoral) not successfully treated with
Plain old Balloon Angioplasty (POBA) or stent and without complications.
12. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal and
beyond the 150mm target zone 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 (INR)
>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
1/06/2015
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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
1/12/2016
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Sample size
Target
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Accrual to date
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Final
60
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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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Austria
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State/province [2]
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Vienna
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Country [3]
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Germany
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State/province [3]
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Bad Krozingen
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Country [4]
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Germany
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State/province [4]
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Leipzig
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Country [5]
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Germany
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State/province [5]
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Munster
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Country [6]
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Germany
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State/province [6]
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Rosenheim
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Country [7]
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New Zealand
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State/province [7]
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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
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical
study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in
subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm
reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated
to generate sonic shockwave energy within the target treatment site and disrupt calcium
within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low
balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to
yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up
rate.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02369848
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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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Universitäts-Herzzentrum Freiburg & 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/NCT02369848
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