Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
NCT ID: NCT02923193
Last Updated: 2023-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
306 participants
INTERVENTIONAL
2017-02-22
2022-06-02
Brief Summary
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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.
Detailed Description
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Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical 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. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
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
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.
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.
Observational Study Eligibility 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.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gunnar Tepe, MD
Role: PRINCIPAL_INVESTIGATOR
RoMed Klinikum Rosenheim
William A Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Main Line Health
Locations
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Arkansas Heart Hospital
Little Rock, Arkansas, United States
Stanford Hospital
Palo Alto, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
UCHealth Northern Colorado
Loveland, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Advocate Health and Hospitals Corporation
Naperville, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Steward St. Elizabeth's Medical Center
Brighton, Maine, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Ascension / St. John Providence
Southfield, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Saint Luke's Cardiovascular Consultants
Kansas City, Missouri, United States
St. Luke's East Hospital
Lee's Summit, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Mount Sinai West
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
NC Heart & Vascular Research
Raleigh, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Ohio Health Research Institute
Columbus, Ohio, United States
St. John Clinic
Bartlesville, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
PinnacleHealth Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Baptist Medical Center
Memphis, Tennessee, United States
St. David's Heart and Vascular dba Austin Heart
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Medizinische Universitaet Graz
Graz, , Austria
Gefäßsambulanz
Vienna, , Austria
Karolinen-Hospital
Arnsberg, , Germany
Universitäts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen, , Germany
Sankt Gertrauden-Krankenhaus
Berlin, , Germany
Leiter Sektion Angiologie
Bonn, , Germany
Medizinische Klinik II
Bruchsal, , Germany
Klinik für Gefäßmedizin
Hamburg, , Germany
Universitätsklinikum Leipzig AoR Leipzig
Leipzig, , Germany
Katholisches Klinikum Mainz
Mainz, , Germany
Evangelisches Krankenhaus Mühlheim an der Ruhr
Mülheim, , Germany
St. Franziskus Hospital
Münster, , Germany
RoMed Klinikum Rosenheim
Rosenheim, , Germany
Auckland City Hospital
Auckland, , New Zealand
Countries
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References
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Nagpal S, Altin SE, McGinigle K, Mangalmurti SS, Adams G, Shammas NW, Mehrle A, Soukas P, Bertolet B, Lansky AJ. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2.
Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: A cohort analysis from the Disrupt PAD III Study
Other Identifiers
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CP 60892
Identifier Type: -
Identifier Source: org_study_id