Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

NCT05007925 | Completed Results DMC FDA Device

• 1 other identifier: CP 65007
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 43

Brief Summary

To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Procedure Success

  Procedure Success defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab at the final timepoint.

  30 days

• Number of Participants With Major Adverse Limb Events (MALE) + Post-Operative Death (POD)

  Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of: * all-cause death * above-ankle amputation of the index limb * major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery

  30 days

• Subjects Without Serious Angiographic Complications

  Subject Success defined as final residual stenosis ≤ 50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab. Serious angiographic complications include (flow-limiting dissection, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab

  30 days

Secondary Outcomes (9)

• Number of Lesions With Technical Success

  30 days

• Number of Patients With Primary Patency

  6 and 12 months

• Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)

  30 days

• Number of Participants With Major Adverse Events (MAE)

  30 days

• VascuQoL Reported as Change From Baseline

  30 days, 6, 12 & 24 months

Study Arms (1)

Single-arm

EXPERIMENTAL

Device: Intravascular Lithotripsy

Interventions

Intravascular Lithotripsy DEVICE

Localized peripheral intravascular lithotripsy

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of subject is ≥ 18.
• Subject is able and willing to comply with all assessments in the study.
• 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.
• 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.
• Estimated life expectancy \>1 year.
• Up to 2 below-the-knee target lesion(s) in native vessels in one or both limbs.
• Target lesion reference vessel diameter (RVD) between 2.0 mm and 4.0 mm by investigator visual estimate.
• Target lesion with ≥70% stenosis by investigator visual estimate.
• Target lesion length is ≤200 mm by investigator visual estimate. Target lesion can be all or part of the 200 mm treated zone.
• Distal reconstitution of at least one pedal vessel (\<50% stenosis) (desert foot excluded).
• 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:
• Angiography requires fluoroscopic evidence of calcification on parallel sides of the vessel and extending \> 50% the length of the lesion.
• IVUS requires presence of ≥270 degrees of calcium over the course of at least 10mm.
• Non-dilatable lesion requires attempted treatment with PTA during the index procedure with residual stenosis \> 50% and no serious angiographic complications.

You may not qualify if:

• Rutherford Category 0, 1, 2 or 6 (target limb).
• 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) .
• History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Subject has known allergy to urethane, nylon, or silicone.
• Myocardial infarction within 30 days prior to enrollment.
• History of stroke within 60 days prior to enrollment.
• Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy.
• Subject is pregnant or nursing.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• 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.
• Covid-19 diagnosis within 90 days.
• The planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesions during the index procedure.
• Planned major amputation (of either leg).

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (43)

UCSF Fresno

Fresno, California, 93720, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford Hospital

Palo Alto, California, 94304, United States

Location

UC Davis Health

Sacramento, California, 95817, United States

Location

St. Helena Hospital

St. Helena, California, 94574, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Medstar Montgomery Medical Center

Olney, Maryland, 20832, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Southcoast Hospitals Group

New Bedford, Massachusetts, 02740, United States

Location

McLaren Bay Heart and Vascular

Bay City, Michigan, 48708, United States

Location

McLaren Greater Lansing

Lansing, Michigan, 48910, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28202, United States

Location

North Carolina Heart & Vascular

Raleigh, North Carolina, 27607, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Ascension St Johns Heart & Vascular Center

Bartlesville, Oklahoma, 74006, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Wellmont Cardiology Services dba CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Texas Health Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Baylor Scott & White - The Heart Hospital Baylor

Plano, Texas, 75093, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

VA Puget Sound Health Care Systems - Seattle

Seattle, Washington, 98108, United States

Location

Karolinen-Hospital Hüsten

Arnsberg, 59759, Germany

Location

Universitäts-Herzzentrum Freiburg & Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitätsklinikum der Ruhr-Universitaet Bochum

Bad Oeynhausen, 32545, Germany

Location

Universitätsklinikum Leipzig AoR

Leipzig, 04103, Germany

Location

Related Publications (1)

• Chandra V, Lansky AJ, Sayfo S, Shammas NW, Soukas P, Park J, Siah M, Babaev A, Shields R, West NEJ, Armstrong E. Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg. 2025 Mar;81(3):710-719.e2. doi: 10.1016/j.jvs.2024.11.003. Epub 2024 Nov 12.

  PMID: 39536842 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Denise Winn
• Organization: Shockwave Medical

dwinn@its.jnj.com

410-991-9311

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 17, 2021
• Study Start: November 18, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 27, 2026
• Last Updated: May 5, 2026
• Results First Posted: August 5, 2025

Record last verified: 2026-04

Locations

DE (4); US (39)