Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Intravascular Lithotripsy

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Karolinen-Hospital Hüsten
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg & Bad Krozingen
  • Bad Oeynhausen, Germany, 32545
    • Universitätsklinikum der Ruhr-Universitaet Bochum
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
• United States
  • California
    • Fresno, California, United States, 93720
      • UCSF Fresno
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Palo Alto, California, United States, 94304
      • Stanford Hospital
    • Sacramento, California, United States, 95817
      • UC Davis Health
    • St. Helena, California, United States, 94574
      • St. Helena Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Maryland
    • Olney, Maryland, United States, 20832
      • MedStar Montgomery Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • New Bedford, Massachusetts, United States, 02740
      • Southcoast Hospitals Group
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Heart and Vascular
    • Lansing, Michigan, United States, 48910
      • McLaren Greater Lansing
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10029
      • Mt. Sinai Hospital
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/NYPH
  • North Carolina
    • Charlotte, North Carolina, United States, 28202
      • Charlotte Radiology
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart & Vascular
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Ascension St Johns Heart & Vascular Center
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health Cardiovascular Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services dba CVA Heart Institute
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons
    • Dallas, Texas, United States, 75231
      • Texas Health Presbyterian Hospital
    • Plano, Texas, United States, 75093
      • Baylor Scott & White - The Heart Hospital Baylor
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care Systems - Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- General Inclusion Criteria

1. Age of subject is ≥ 18.
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.

   • Angiographic Inclusion Criteria
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:

- General Exclusion Criteria

1. Rutherford Category 0, 1, 2 or 6 (target limb).
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.

    • Angiographic Exclusion Criteria
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm	Device: Intravascular Lithotripsy; Localized peripheral intravascular lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lesions With Technical Success	Lesion Success defined as final residual stenosis ≤50% in the target lesion without serious angiographic complications as assessed by the angiographic core lab	30 days
Number of Patients With Primary Patency	Primary Patency at 6 and 12 months defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions in a flow pathway, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR)	6 and 12 months
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CD-TLR)	Clinically-driven target lesion revascularization (CD-TLR) defined as a composite of: CD-TLR; Major target limb amputation	30 days
Number of Participants With Major Adverse Events (MAE)	Major Adverse Events (MAE) at 30 days defined as a composite of: Need for emergency surgical revascularization of target limb; Unplanned target limb major amputation (above the ankle); Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization; Perforations that require an intervention, including bail-out stenting	30 days
VascuQoL Reported as Change From Baseline	The VascuQoL-6 is a short, disease-specific questionnaire used to measure health-related quality of life (HRQoL) in patients with peripheral arterial disease (PAD), specifically those with intermittent claudication and critical limb ischemia.	30 days, 6, 12 & 24 months
Ankle-brachial Index (ABI) Reported as Change From Baseline	The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.	30 days
Rutherford Category Reported as Change From Baseline	The Rutherford classification is a system used to categorize the severity of peripheral artery disease (PAD), specifically chronic limb-threatening ischemia (CLTI), based on symptoms and tissue loss. The classification ranges are from Class 0 where no symptoms of PAD are present and the patient has no claudication or tissue loss to Class 6 where patients have extensive tissue loss, including gangrene, that extends above the transmetatarsal level (the area above the bones of the foot). A higher score on the Rutherford Classification Scale is indicative of a worse outcome.	30 days
Toe-brachial Index (TBI) Reported as Change From Baseline	The TBI is the ratio of systolic blood pressure measured at the toe to systolic blood pressure at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.	30 Days
Number of Participants Free From Major Target Limb Amputation		30 Days

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CP 65007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes