JetStream Atherectomy for the Treatment of In-stent Restenosis
Public ClinicalTrials.gov record NCT02730234. 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
JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease. This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.
Study identification
- NCT ID
- NCT02730234
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 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
- Mar 31, 2016
- Primary completion
- Feb 3, 2020
- Completion
- Sep 23, 2020
- Last update posted
- Aug 10, 2021
2016 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eastern Colorado Healthcare System | Denver | Colorado | 80220 | — |
| Florida Hospital Heartland Medical Center | Sebring | Florida | 33872 | — |
| Advocate Health | Downers Grove | Illinois | 60515 | — |
| Midwest Cardiovascular Research Foundation/Trinity Medical Center | Bettendorf | Iowa | 52722 | — |
| Midwest Cardiovascular Research Foundation/Genesis Medical Center | Davenport | Iowa | 52722 | — |
| Endovascular Technologies, LLC | Shreveport | Louisiana | 71103 | — |
| Atlantic Medical Imaging | Galloway | New Jersey | 08205 | — |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87101 | — |
| Promedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| US Departmetn of Veterans Affairs, Oklahoma VA Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| VA North Texas Health Care System: Dallas VA Medical Center | Dallas | Texas | 75216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02730234, 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 Aug 10, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02730234 live on ClinicalTrials.gov.