Ireland
--:--IST
Latest
Active, not recruiting Not applicable

SELUTION SLR™ 014 In-stent Restenosis

NCT04280029 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2020-07-06
Last updated
2025-12-17

Condition(s) studied

Coronary Restenosis

Investigational drug(s) / intervention(s)

SELUTION SLR 014 DEBStandard of Care

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).

Standard of Care: POBA or FDA-approved commercially available -limus eluting DES

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Target Lesion Failure (TLF) — 12 months post-index procedure

Trial sites (48)

FacilityCityRegionStatus
Loma Linda University Loma Linda California
Cedars-Sinai Medical Center Los Angeles California
Harbor-UCLA Medical Center Torrance California
ClinRe 001-001 Thornton Colorado
MedStar Heart Institute Washington D.C. District of Columbia
University of Florida Health Jacksonville Florida
Baptist Cardiac & Vascular Institute Miami Florida
Atlanta VA Medical Center Atlanta Georgia
Piedmont Heart Institute Atlanta Georgia
Ascension St Vincents Heart Center Indianapolis Indiana
Ascension Via Christi Wichita Kansas
University of Maryland Baltimore Maryland
Beth Israel Deaconess Medical Centre, Harvard Medical School Boston Massachusetts
Ascension Borgess Heart Institute Kalamazoo Michigan
Beaumont Hospital Royal Oak Michigan
Ascension St John Hospital Southfield Michigan
Minneapolis Heart Institute Minneapolis Minnesota
Manchester Catholic Medical Center Manchester New Hampshire
Morristown Medical Center Morristown New Jersey
Rutgers, Robert Wood Johnson Medical School New Brunswick New Jersey
Mount Sinai Hospital New York New York
St. Francis Hospital & Heart Center Roslyn New York
Moses H. Cone Memorial Hospital Greensboro North Carolina
NC Heart and Vascular Research, LLC Raleigh North Carolina
The Christ Hospital Cincinnati Ohio
Integris Oklahoma City Oklahoma
UPMC Pinnacle Health Harrisburg Pennsylvania
Pennsylvania State University Milton S. Hershey Medical Center Hershey Pennsylvania
Lifespan Cardiovascular Institute Providence Rhode Island
HCA Centennial Nashville Tennessee
Baylor Scott & White Dallas Texas
Texas Tech University Health Sciences Center Lubbock Texas
Baylor Scott & White Temple Texas
HCA Chippenham/VA Cardiovascular Specialists Richmond Virginia
HartCentrum Hasslet, Jessa Ziekenhuis Hasselt Belgium
Instituto Dante Pazzanese de Cardiologia São Paulo São Paulo
Instituto do Coração - São Paulo University São Paulo São Paulo
Hamilton Health Sciences Hamilton Ontario
Clinique Valmy Dijon France
Hôpital privé Jacques Cartier Massy France

+ 8 more sites — see the full list on the official registry below.

More M.A. Med Alliance S.A. trials in Italy

The SELUTION DeNovo Study Active, not recruiting
SELUTION4BTK Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04280029 on ClinicalTrials.gov ↗ ← All trials in Italy