Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Public ClinicalTrials.gov record NCT02923193. 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
Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand. In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries. The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
Study identification
- NCT ID
- NCT02923193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 306 participants
Conditions and interventions
Conditions
Interventions
Device · Drug
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
- Feb 22, 2017 (Actual)
- Primary completion
- May 12, 2020 (Actual)
- Completion
- Jun 2, 2022 (Actual)
- Last update posted
- Dec 20, 2023
2017 – 2022
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| Stanford Hospital | Palo Alto | California | 94304 | — |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | — |
| UCHealth Northern Colorado | Loveland | Colorado | 80538 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| MedStar Cardiovascular Research Network @ 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 | — |
| Advocate Health and Hospitals Corporation | Naperville | Illinois | 60540 | — |
| Prairie Education & Research Cooperative | Springfield | Illinois | 62769 | — |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | — |
| Steward St. Elizabeth's Medical Center | Brighton | Maine | 02135 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48431 | — |
| Ascension / St. John Providence | Southfield | Michigan | 48075 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Saint Luke's Cardiovascular Consultants | Kansas City | Missouri | 64111 | — |
| St. Luke's East Hospital | Lee's Summit | Missouri | 64086 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | — |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | — |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| St. John Clinic | Bartlesville | Oklahoma | 74006 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| PinnacleHealth Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | — |
| Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania | 19141 | — |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | — |
| Tennova Healthcare - Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | — |
| Baptist Medical Center | Memphis | Tennessee | 38120 | — |
| St. David's Heart and Vascular dba Austin Heart | Austin | Texas | 78756 | — |
| Baylor College of Medicine | 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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02923193, 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 Dec 20, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02923193 live on ClinicalTrials.gov.