Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
418 participants
INTERVENTIONAL
2020-07-06
2029-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
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
Standard of Care
POBA or FDA-approved commercially available -limus eluting DES
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Cordis US Corp.
INDUSTRY
M.A. Med Alliance S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald E Cutlip, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Loma Linda University
Loma Linda, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
ClinRe 001-001
Thornton, Colorado, United States
MedStar Heart Institute
Washington D.C., District of Columbia, United States
University of Florida Health
Jacksonville, Florida, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, United States
Atlanta VA Medical Center
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Ascension St Vincents Heart Center
Indianapolis, Indiana, United States
Ascension Via Christi
Wichita, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Centre, Harvard Medical School
Boston, Massachusetts, United States
Ascension Borgess Heart Institute
Kalamazoo, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Ascension St John Hospital
Southfield, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Manchester Catholic Medical Center
Manchester, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Integris
Oklahoma City, Oklahoma, United States
UPMC Pinnacle Health
Harrisburg, Pennsylvania, United States
Pennsylvania State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Lifespan Cardiovascular Institute
Providence, Rhode Island, United States
HCA Centennial
Nashville, Tennessee, United States
Baylor Scott & White
Dallas, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Baylor Scott & White
Temple, Texas, United States
HCA Chippenham/VA Cardiovascular Specialists
Richmond, Virginia, United States
HartCentrum Hasslet, Jessa Ziekenhuis
Hasselt, , Belgium
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
Instituto do Coração - São Paulo University
São Paulo, São Paulo, Brazil
Hamilton Health Sciences
Hamilton, Ontario, Canada
Clinique Valmy
Dijon, , France
Hôpital privé Jacques Cartier
Massy, , France
Clinique Saint Hilaire
Rouen, , France
CHU Toulouse Rangueil
Toulouse, , France
Maria Cecilia Hospital
Cotignola, , Italy
Instituto Clinico Humanitas Milan
Milan, , Italy
Center Azienda Ospedaliero Universitaria de Padova
Padua, , Italy
Amsterdam UMC, Academic Medical Centre
Amsterdam, AZ, Netherlands
UMC Utrecht
Utrecht, CX, Netherlands
UMCG
Groningen, GZ, Netherlands
Countries
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References
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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.
Other Identifiers
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SEL-003-2019
Identifier Type: -
Identifier Source: org_study_id