Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
NCT ID: NCT05007925
Last Updated: 2025-08-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2021-11-18
2026-04-01
Brief Summary
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Post-market, prospective , multi-center, single-arm study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm
Intravascular Lithotripsy
Localized peripheral intravascular lithotripsy
Interventions
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Intravascular Lithotripsy
Localized peripheral intravascular lithotripsy
Eligibility Criteria
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Inclusion Criteria
2. Subject is able and willing to comply with all assessments in the study.
3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
4. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5; or Rutherford 3 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
5. Estimated life expectancy \>1 year.
6. Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
7. Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
8. Target lesion with ≥70% stenosis by investigator visual estimate.
9. Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
10. Distal reconstitution of at least one pedal vessel (\<50% stenosis) (desert foot excluded).
11. Evidence of at least moderate calcification at the target lesion site by angiography/IVUS OR non-dilatable lesion indicating presence of calcium. Must meet one of the following:
1. Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending \> 50% the length of the lesion.
2. IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
3. Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis \> 50% and no serious angiographic complications.
Exclusion Criteria
2. Osteomyelitis or deep soft tissue infection extending proximal from the metatarsals that cannot be treated with an individual toe ray amputation or transmetatarsal amputation (TMA) .
3. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
4. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
5. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
6. Subject has known allergy to urethane, nylon, or silicone.
7. Myocardial infarction within 30 days prior to enrollment.
8. History of stroke within 60 days prior to enrollment.
9. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
10. Subject is pregnant or nursing.
11. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
12. 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.
13. Covid-19 diagnosis within 90 days.
14. The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
15. Planned major amputation (of either leg).
16. Acute limb ischemia.
17. Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot).
18. Subject has an anticipated life span of less than one (1) year.
19. Subject already enrolled into this study.
20. Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g., embolism).
21. Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism ).
22. Failed PTA in target lesion during index procedure with angiographic evidence of serious angiographic complications .
23. Target lesion includes in-stent restenosis.
24. Evidence of aneurysm or thrombus in target vessel.
25. No calcium or mild calcium in the target lesion.
26. Target lesion within native or synthetic vessel grafts.
27. 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.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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UCSF Fresno
Fresno, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford Hospital
Palo Alto, California, United States
UC Davis Health
Sacramento, California, United States
St. Helena Hospital
St. Helena, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Medstar Montgomery Medical Center
Olney, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Southcoast Hospitals Group
New Bedford, Massachusetts, United States
McLaren Bay Heart and Vascular
Bay City, Michigan, United States
McLaren Greater Lansing
Lansing, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Mt. Sinai Hospital
New York, New York, United States
Columbia University Irving Medical Center/NYPH
New York, New York, United States
Charlotte Radiology
Charlotte, North Carolina, United States
North Carolina Heart & Vascular
Raleigh, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Ascension St Johns Heart & Vascular Center
Bartlesville, Oklahoma, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Wellmont Cardiology Services dba CVA Heart Institute
Kingsport, Tennessee, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Texas Health Presbyterian Hospital
Dallas, Texas, United States
Baylor Scott & White - The Heart Hospital Baylor
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
VA Puget Sound Health Care Systems - Seattle
Seattle, Washington, United States
Karolinen-Hospital Hüsten
Arnsberg, , Germany
Universitäts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen, , Germany
Universitätsklinikum der Ruhr-Universitaet Bochum
Bad Oeynhausen, , Germany
Universitätsklinikum Leipzig AoR
Leipzig, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP 65007
Identifier Type: -
Identifier Source: org_study_id
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