Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
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.
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
- Enrollment
- 250 participants
Conditions and interventions
Conditions
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 17, 2021
- Primary completion
- Mar 24, 2024
- Completion
- Mar 26, 2026
- Last update posted
- May 4, 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 4, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05007925 live on ClinicalTrials.gov.