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NCT04280029 · ClinicalTrials.gov registry record · NA
SELUTION SLR™ 014 In-stent Restenosis
A NA study of Coronary Restenosis, sponsored by M.A. Med Alliance S.A..
- Active
- Registry status
- NA
- Development phase
- 418
- Enrollment target
- 20
- Study locations
NCT04280029: Active NA study of Coronary Restenosis, sponsored by M.A. Med Alliance S.A..
NCT04280029 is a NA study of Coronary Restenosis that is active but no longer recruiting, run by M.A. Med Alliance S.A.. The registered enrollment target is 418 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04280029, a NA study of Coronary Restenosis, is active but no longer recruiting, sponsored by M.A. Med Alliance S.A..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 418 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for 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 SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or 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.
Conditions Studied
Interventions
- DEVICE SELUTION SLR 014 DEB
- DEVICE Standard of Care
Study Locations (20)
California
- Loma Linda University - Loma Linda
- Cedars-Sinai Medical Center - Los Angeles
- Harbor-UCLA Medical Center - Torrance
Michigan
- Ascension Borgess Heart Institute - Kalamazoo
- Beaumont Hospital - Royal Oak
- Ascension St John Hospital - Southfield
Florida
- University of Florida Health - Jacksonville
- Baptist Cardiac & Vascular Institute - Miami
Georgia
- Atlanta VA Medical Center - Atlanta
- Piedmont Heart Institute - Atlanta
New Jersey
- Morristown Medical Center - Morristown
- Rutgers, Robert Wood Johnson Medical School - New Brunswick
Colorado
- ClinRe 001-001 - Thornton
District of Columbia
- MedStar Heart Institute - Washington D.C.
Indiana
- Ascension St Vincents Heart Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2029-08 |
| Phase | NA |
What the registry record for NCT04280029 still lists
NCT04280029 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Coronary Restenosis appearing as the primary indexed condition, and to 2 interventions - of which SELUTION SLR 014 DEB is the first listed.
NCT04280029 names 20 study sites across 13 states, led by California, Michigan, Florida.
Frequently Asked Questions
What is clinical trial NCT04280029 about?
NCT04280029 is a clinical study titled "SELUTION SLR™ 014 In-stent Restenosis". Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatm...
What is the current status of trial NCT04280029?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 418 participants. The study started on 2020-07-06. Estimated completion is 2029-08.
What conditions does trial NCT04280029 study?
This clinical trial studies the following conditions: Coronary Restenosis.
What interventions are being tested in trial NCT04280029?
The interventions under investigation include: SELUTION SLR 014 DEB (DEVICE), Standard of Care (DEVICE).
Who is sponsoring clinical trial NCT04280029?
This trial is sponsored by M.A. Med Alliance S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04280029 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Restenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04280029's enrollment target sits among peer trials
418 240th of 2000 higher than 1,760 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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