SELUTION SLR™ 014 In-stent Restenosis (SELUTION4ISR)

April 24, 2024 updated by: M.A. Med Alliance S.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial will enroll up to 418 randomized subjects (including up to 60 subjects in an angiographic and optical coherence tomography [OCT] sub-study) at up to 80 sites in the United States (US), Canada, Brazil, and Europe (EU). A minimum of 50% of the subjects will be enrolled in the US.

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 group.

A subset of up to 60 subjects will be enrolled in the angiographic and OCT sub-study and undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up/assessment.

Study Type

Interventional

Enrollment (Estimated)

418

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Recruiting
        • HartCentrum Hasslet, Jessa Ziekenhuis
        • Principal Investigator:
          • Pascal Vranckx
        • Contact:
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 900040-371
        • Withdrawn
        • Instituto de Cardiologia de Porto Alegre
      • Porto Alegre, RS, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas
        • Contact:
        • Principal Investigator:
          • Marco Wainstein, MD
    • SP
      • São Paulo, SP, Brazil, 04012-180
        • Not yet recruiting
        • Instituto Dante Pazzanese de Cardiologia
        • Contact:
        • Principal Investigator:
          • Rodolfo Staico
      • São Paulo, SP, Brazil, 05403-900
        • Recruiting
        • Instituto do Coração - São Paulo University
        • Principal Investigator:
          • Alexandre Abizaid
        • Contact:
  • France
      • Dijon, France, 21000
        • Recruiting
        • Clinique Valmy
        • Contact:
        • Principal Investigator:
          • Laurent Mock
      • Massy, France, 91300
        • Recruiting
        • Hôpital privé Jacques Cartier
        • Principal Investigator:
          • Antoinette Nylon
        • Contact:
      • Rouen, France, 76000
        • Recruiting
        • Clinique Saint Hilaire
        • Contact:
        • Principal Investigator:
          • Jacques Berland
      • Toulouse, France, 31400
        • Recruiting
        • CHU Toulouse Rangueil
        • Contact:
        • Principal Investigator:
          • Jérôme Roncalli
  • Italy
      • Cotignola, Italy, 48033
        • Recruiting
        • Maria Cecilia Hospital
        • Contact:
        • Principal Investigator:
          • Roberto Nerla
      • Milano, Italy, 20089
        • Recruiting
        • Instituto Clinico Humanitas Milan
        • Contact:
        • Principal Investigator:
          • Giulio Stefanini
      • Padova, Italy, 35128
        • Recruiting
        • Center Azienda Ospedaliero Universitaria de Padova
        • Principal Investigator:
          • Giuseppe Tarantini
        • Contact:
      • Pisa, Italy, 56124
        • Recruiting
        • Cisanello Hospital, University of Pisa
        • Contact:
        • Principal Investigator:
          • Marco De Carlo
  • Netherlands
    • AZ
      • Amsterdam, AZ, Netherlands, 1105
        • Recruiting
        • Amsterdam UMC, Academic Medical Centre
        • Contact:
        • Principal Investigator:
          • José Henriques
    • CX
      • Utrecht, CX, Netherlands, 3584
        • Recruiting
        • UMC Utrecht
        • Contact:
        • Principal Investigator:
          • Michiel Voskuil
    • GZ
      • Groningen, GZ, Netherlands, 9718
        • Recruiting
        • UMCG
        • Contact:
        • Principal Investigator:
          • Joanna J Wykrzykowska
  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
        • Principal Investigator:
          • Vinoy Prasad, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Suhail Dohad, MD
        • Contact:
      • Torrance, California, United States, 90502
        • Recruiting
        • Harbor-UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Thomas, MD
    • Colorado
      • Thornton, Colorado, United States, 80023
        • Not yet recruiting
        • ClinRe 001-001
        • Contact:
        • Principal Investigator:
          • Ehrin J Armstrong, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Steven Pfau, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Heart Institute
        • Principal Investigator:
          • Itsik Ben-Dor, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Health
        • Principal Investigator:
          • Daniel Soffer, MD
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Cardiac & Vascular Institute
        • Principal Investigator:
          • Ramon Quesada, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Principal Investigator:
          • Gautam Kumar, MD
        • Contact:
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Katherine Kunkel, MD
        • Contact:
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Principal Investigator:
          • Ravi Ramana, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St Vincents Heart Center
        • Contact:
        • Principal Investigator:
          • Mike Kourany, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Principal Investigator:
          • Bassem Chehab, MD
        • Contact:
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Principal Investigator:
          • Craig Walker, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Diljon Chahal, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Kevin Croce, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Centre, Harvard Medical School
        • Contact:
        • Principal Investigator:
          • Marie-France Poulin, MD
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Ascension Borgess Heart Institute
        • Contact:
        • Principal Investigator:
          • Tim Fischell, MD
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Ivan Hanson, MD
        • Contact:
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension St John Hospital
        • Principal Investigator:
          • Amir Kaki, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Contact:
        • Principal Investigator:
          • Emmanouil Brilakis, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital
        • Principal Investigator:
          • Jasvinder Singh, MD
        • Contact:
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Recruiting
        • Manchester Catholic Medical Center
        • Principal Investigator:
          • Stephan Heo, MD
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
        • Principal Investigator:
          • Jordan Safirstein, MD
      • New Brunswick, New Jersey, United States, 08901
        • Not yet recruiting
        • Rutgers, Robert Wood Johnson Medical School
        • Principal Investigator:
          • Michael Huang, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Samin Sharma, MD
        • Contact:
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital & Heart Center
        • Principal Investigator:
          • Allen Jeremias, MD
        • Contact:
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Moses H. Cone Memorial Hospital
        • Principal Investigator:
          • Muhammad Arida, MD
        • Contact:
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research, LLC
        • Principal Investigator:
          • George Adams, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Jarrod Frizzell, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Khaled Ziada, MD
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System
        • Contact:
        • Principal Investigator:
          • Abdulhay Albrini, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris
        • Principal Investigator:
          • George Chrysant, MD
        • Contact:
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Recruiting
        • UPMC Pinnacle Health
        • Contact:
        • Principal Investigator:
          • Anay Pradhan, MD
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Pennsylvania State University Milton S. Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Ian Gilchrist, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
        • Contact:
        • Principal Investigator:
          • Jinnette D Abbott, MD
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Lifespan Cardiovascular Institute
        • Contact:
        • Principal Investigator:
          • Jinnette D Abbott, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • HCA Centennial
        • Principal Investigator:
          • Brian Jefferson, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Scott & White
        • Principal Investigator:
          • Robert Stoler, MD
        • Contact:
      • Lubbock, Texas, United States, 79430
        • Terminated
        • Texas Tech University Health Sciences Center
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White
        • Contact:
        • Principal Investigator:
          • Robert J Widmer, MD
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • HCA Chippenham/VA Cardiovascular Specialists
        • Contact:
        • Principal Investigator:
          • Nayef Abouzaki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Clinical Inclusion Criteria:

  1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
  2. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
  3. 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.
  4. 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.
  5. Life expectancy >1 year in opinion of investigator.
  6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

Angiographic Inclusion Criteria

  1. Target lesion is within a native coronary artery or major branch.
  2. 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.
  3. 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.
  4. Target lesion is ≤ 26 mm in length.
  5. Target lesion has diameter stenosis of > 50% and ≤ 99% by visual estimate.
  6. Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
  7. 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.

Clinical Exclusion Criteria:

  1. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
  2. ST-elevation myocardial infarction (STEMI) within 30 days.
  3. 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.
  4. Target lesion is located within a bifurcation with planned treatment of side branch vessel.
  5. 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).
  6. Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
  7. Previous PCI of the target vessel within 30 days.
  8. Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
  9. 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.
  10. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
  11. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
  12. Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
  13. Documented left ventricular ejection fraction (LVEF) < 25%.
  14. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Angiographic Exclusion Criteria

  1. Target lesion is a total occlusion or has evidence of thrombus.
  2. Target lesion involves an unprotected left main.
  3. Target lesion has > 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SELUTION SLR™ DEB
The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).
Device: SELUTION SLR™ DEB
The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).
Active Comparator: Control Treatment
POBA or FDA-approved -limus DES
Device: Control
POBA or FDA-approved -limus DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure
Time Frame: 12 months post-index procedure

The primary safety and efficacy endpoint is TLF at 12 months post-index procedure for SELUTION SLR 014 DEB versus SOC in all patients. TLF is defined as all cardiac death, target vessel myocardial infarction (MI) or clinically driven TLF.

MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.
12 months post-index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment minimal luminal diameter (MLD)
Time Frame: at 12 months
The powered secondary endpoint will be in-segment minimal luminal diameter (MLD) at 12 months (after documented completion of 12 months of clinical follow-up) in the angiographic follow-up subset.
at 12 months
Lesion Success
Time Frame: at 12 months
Attainment of < 30% residual stenosis of target lesion using any percutaneous method.
at 12 months
Device success
Time Frame: at 12 months
Attainment of < 30% residual stenosis of the target lesion using the assigned study device only.
at 12 months
Procedure Success
Time Frame: at 12 months
Attainment of < 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), a composite of all-cause death, MI or clinically driven TLR.
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.A. Med Alliance S.A.

Collaborators

Iqvia Pty Ltd

Investigators

  • Principal Investigator: Ron Waksman, MD, MedStar Heart Institute
  • Principal Investigator: Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEL-003-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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