SELUTION SLR™ 014 In-stent Restenosis
Public ClinicalTrials.gov record NCT04280029. 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
SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB or Standard of Care (SOC) to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or Balloon Angioplasty (BA). A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR 014 DEB in all patients.
Study identification
- NCT ID
- NCT04280029
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 418 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
- Jul 6, 2020 (Actual)
- Primary completion
- Aug 15, 2025 (Actual)
- Completion
- Aug 2029 (Estimated)
- Last update posted
- Oct 20, 2026
2020 – 2029
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| ClinRe 001-001 | Thornton | Colorado | 80023 | — |
| MedStar Heart Institute | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida Health | Jacksonville | Florida | 32209 | — |
| Baptist Cardiac & Vascular Institute | Miami | Florida | 33176 | — |
| Atlanta VA Medical Center | Atlanta | Georgia | 30033 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Ascension St Vincents Heart Center | Indianapolis | Indiana | 46260 | — |
| Ascension Via Christi | Wichita | Kansas | 67226 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Beth Israel Deaconess Medical Centre, Harvard Medical School | Boston | Massachusetts | 02215 | — |
| Ascension Borgess Heart Institute | Kalamazoo | Michigan | 49048 | — |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Ascension St John Hospital | Southfield | Michigan | 48075 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Manchester Catholic Medical Center | Manchester | New Hampshire | 03102 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers, Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| St. Francis Hospital & Heart Center | Roslyn | New York | 11576 | — |
| Moses H. Cone Memorial Hospital | Greensboro | North Carolina | 27401 | — |
| NC Heart and Vascular Research, LLC | Raleigh | North Carolina | 27607 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Integris | Oklahoma City | Oklahoma | 73112 | — |
| UPMC Pinnacle Health | Harrisburg | Pennsylvania | 17104 | — |
| Pennsylvania State University Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Lifespan Cardiovascular Institute | Providence | Rhode Island | 02903 | — |
| HCA Centennial | Nashville | Tennessee | 37203 | — |
| Baylor Scott & White | Dallas | Texas | 75204 | — |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | — |
| Baylor Scott & White | Temple | Texas | 76508 | — |
| HCA Chippenham/VA Cardiovascular Specialists | Richmond | Virginia | 23225 | — |
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 NCT04280029, 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 Oct 20, 2026 · 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 NCT04280029 live on ClinicalTrials.gov.