SELUTION SLR™ 014 In-stent Restenosis

NCT04280029 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SEL-003-2019
• Study Type: interventional
• Target: 418
• Locations: 7 countries
• Sites: 48

Brief 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

Keywords

In-stent restenosis; Drug Eluting Balloon; Coronary

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  12 months post-index procedure

Secondary Outcomes (23)

• Device success

  Index Procedure

• Lesion Success

  Index Procedure

• Procedure Success

  Index Procedure

• Composite Safety Endpoint

  Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up

• All-cause Mortality

  Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up

Other Outcomes (1)

• Cardiac Biomarker Elevations

  Peri-Procedural

Study Arms (2)

SELUTION SLR 014 DEB

EXPERIMENTAL

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: SELUTION SLR 014 DEB

Standard Of Care

ACTIVE COMPARATOR

POBA or FDA-approved commercially available -limus eluting DES

Device: Standard of Care

Interventions

SELUTION SLR 014 DEB DEVICE

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).

SELUTION SLR 014 DEB

Standard of Care DEVICE

POBA or FDA-approved commercially available -limus eluting DES

Standard Of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age is ≥ 18 years or minimum legal age as required by local regulations.
• Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
• Subject presents with chronic coronary syndrome (CCS) (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for percutaneous coronary intervention (PCI) and planned intervention.
• Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
• Life expectancy \>1 year in opinion of investigator.
• Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
• Target lesion is within a native coronary artery or major branch.
• Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
• Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion \> 2.
• Target lesion is ≤ 26 mm in length.
• Target lesion has diameter stenosis of \> 50% and ≤ 99% by visual estimate.
• Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
• Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be \> 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment.

You may not qualify if:

• Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
• ST-elevation myocardial infarction (STEMI) within 30 days.
• Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
• Target lesion is located within a bifurcation with planned treatment of side branch vessel.
• Target lesion is the 3rd or greater stent failure (i.e., more than two \[2\] layers of stent are present at any segment of the target lesion).
• Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
• Previous PCI of the target vessel within 30 days.
• Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
• Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation.
• Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
• History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
• Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
• Documented left ventricular ejection fraction (LVEF) \< 25%.
• Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
• Target lesion is a total occlusion or has evidence of thrombus.

Sponsors & Collaborators

• M.A. Med Alliance S.A.: lead
• Iqvia Pty Ltd: collaborator
• Cordis US Corp.: collaborator

Study Sites (48)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

ClinRe 001-001

Thornton, Colorado, 80023, United States

Location

MedStar Heart Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health

Jacksonville, Florida, 32209, United States

Location

Baptist Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Ascension St Vincents Heart Center

Indianapolis, Indiana, 46260, United States

Location

Ascension Via Christi

Wichita, Kansas, 67226, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Centre, Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Ascension Borgess Heart Institute

Kalamazoo, Michigan, 49048, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Ascension St John Hospital

Southfield, Michigan, 48075, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Manchester Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

Location

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Integris

Oklahoma City, Oklahoma, 73112, United States

Location

UPMC Pinnacle Health

Harrisburg, Pennsylvania, 17104, United States

Location

Pennsylvania State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Lifespan Cardiovascular Institute

Providence, Rhode Island, 02903, United States

Location

HCA Centennial

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White

Dallas, Texas, 75204, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

HCA Chippenham/VA Cardiovascular Specialists

Richmond, Virginia, 23225, United States

Location

HartCentrum Hasslet, Jessa Ziekenhuis

Hasselt, Belgium

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-180, Brazil

Location

Instituto do Coração - São Paulo University

São Paulo, São Paulo, 05403-900, Brazil

Location

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Clinique Valmy

Dijon, 21000, France

Location

Hôpital privé Jacques Cartier

Massy, 91300, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

Maria Cecilia Hospital

Cotignola, 48033, Italy

Location

Instituto Clinico Humanitas Milan

Milan, 20089, Italy

Location

Center Azienda Ospedaliero Universitaria de Padova

Padua, 35128, Italy

Location

Amsterdam UMC, Academic Medical Centre

Amsterdam, AZ, 1105, Netherlands

Location

UMC Utrecht

Utrecht, CX, 3584, Netherlands

Location

UMCG

Groningen, GZ, 9718, Netherlands

Location

Related Publications (1)

• Cutlip DE, Mehran R, Doros G, Kaplinskiy V, Lee J, Zheng L, Kausik M, Osborn E, Waksman R. 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: Rationale and design. Am Heart J. 2025 Jun;284:11-19. doi: 10.1016/j.ahj.2025.02.001. Epub 2025 Feb 12.

  PMID: 39952378 DERIVED

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Donald E Cutlip, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: July 6, 2020
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (34); BE (1); BR (2); CA (1); IT (3); NL (3); FR (4)