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Completed Not applicable Interventional Results available

Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System

ClinicalTrials.gov ID: NCT05007925

Public ClinicalTrials.gov record NCT05007925. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05007925
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Shockwave Medical, Inc.
Industry
Enrollment
250 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 18, 2021 (Actual)
Primary completion
Mar 25, 2024 (Actual)
Completion
Mar 27, 2026 (Actual)
Last update posted
May 5, 2026

2021 – 2026

United States locations

U.S. sites
39
U.S. states
22
U.S. cities
36
Facility City State ZIP Site status
UCSF Fresno Fresno California 93720 —
Scripps Memorial Hospital La Jolla California 92037 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Stanford Hospital Palo Alto California 94304 —
UC Davis Health Sacramento California 95817 —
St. Helena Hospital St. Helena California 94574 —
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010 —
Tallahassee Memorial Hospital Tallahassee Florida 32308 —
Piedmont Heart Institute Atlanta Georgia 30309 —
Rush University Medical Center Chicago Illinois 60612 —
Midwest Cardiovascular Research Foundation Davenport Iowa 52803 —
Medstar Montgomery Medical Center Olney Maryland 20832 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Southcoast Hospitals Group New Bedford Massachusetts 02740 —
McLaren Bay Heart and Vascular Bay City Michigan 48708 —
McLaren Greater Lansing Lansing Michigan 48910 —
North Mississippi Medical Center Tupelo Mississippi 38801 —
St. Luke's Hospital Kansas City Missouri 64111 —
Barnes-Jewish Hospital St Louis Missouri 63110 —
NYU Langone Health New York New York 10016 —
NYU Langone Medical Center New York New York 10016 —
Mt. Sinai Hospital New York New York 10029 —
Columbia University Irving Medical Center/NYPH New York New York 10032 —
Charlotte Radiology Charlotte North Carolina 28202 —
North Carolina Heart & Vascular Raleigh North Carolina 27607 —
The Christ Hospital Cincinnati Ohio 45219 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Ohio Health Research Institute Columbus Ohio 43214 —
Ascension St Johns Heart & Vascular Center Bartlesville Oklahoma 74006 —
Bryn Mawr Hospital Bryn Mawr Pennsylvania 19010 —
Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania 17101 —
The Miriam Hospital Providence Rhode Island 02906 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Wellmont Cardiology Services dba CVA Heart Institute Kingsport Tennessee 37660 —
Cardiothoracic and Vascular Surgeons Austin Texas 78756 —
Texas Health Presbyterian Hospital Dallas Texas 75231 —
Baylor Scott & White - The Heart Hospital Baylor Plano Texas 75093 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
VA Puget Sound Health Care Systems - Seattle Seattle Washington 98108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05007925, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05007925 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →