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SELUTION SLR™ 014 In-stent Restenosis

NCT04280029 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2025-12-17

No results posted yet for this 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

  • Coronary Restenosis

Interventions

DEVICE

SELUTION SLR 014 DEB

The SELUTION Sustained Limus Release (SLR)™ 014 drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal angioplasty (PTA) balloon catheter coated with a drug (Sirolimus).

DEVICE

Standard of Care

POBA or FDA-approved commercially available -limus eluting DES

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Cordis US Corp.

    collaborator INDUSTRY

  • M.A. Med Alliance S.A.

    lead INDUSTRY

Principal Investigators

  • Donald E Cutlip, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2025-08-15
Completion
2029-08-31
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • France
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280029 on ClinicalTrials.gov