DISRUPT PAD III Observational Study
Public ClinicalTrials.gov record NCT05881421. 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, Post-Market, Observational Study (OS) of the Shockwave Medical, Inc. Intravascular Lithotripsy System in Peripheral Arteries
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions. Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
Study identification
- NCT ID
- NCT05881421
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,373 participants
Conditions and interventions
Conditions
Interventions
Not listed
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 15, 2017
- Primary completion
- Jun 9, 2021
- Completion
- Jun 9, 2021
- Last update posted
- May 30, 2023
2017 – 2021
United States locations
- U.S. sites
- 26
- U.S. states
- 21
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Hospital | Palo Alto | California | 94304 | — |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | — |
| UCHealth Northern Colorado | Loveland | Colorado | 80538 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Tallahassee Research Institute Inc. | Tallahassee | Florida | 32308 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | — |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | — |
| Steward St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| St. Luke's Cardiovascular Consultants | Kansas City | Missouri | 64111 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| NC Heart & Vascular Research, LLC | Raleigh | North Carolina | 27607 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| St. John Clinic | Bartlesville | Oklahoma | 74006 | — |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| Pinnacle Health Cardiovascular Institute | Harrisburg | Pennsylvania | 17101 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Baptist Medical Center | Memphis | Tennessee | 38120 | — |
| St. David's Heart and Vascular (Austin Heart) | Austin | Texas | 78756 | — |
| Baylor Clinic McNair Campus | Houston | Texas | 77030 | — |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | — |
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.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05881421, 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 30, 2023 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05881421 live on ClinicalTrials.gov.