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ACTIVE NOT RECRUITING NA

SELUTION SLR™ 014 In-stent Restenosis

NCT04280029 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 418 participants
Start Date 2020-07-06
Est. Completion 2029-08
Phase NA

Sponsor

M.A. Med Alliance S.A.

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04280029

The ClinicalTrials.gov registry entry for NCT04280029 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.A. Med Alliance S.A., which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04280029 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Michigan, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04280029?

The interventions under investigation include: SELUTION SLR 014 DEB (DEVICE), Standard of Care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04280029?

This trial is sponsored by M.A. Med Alliance S.A., which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial