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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
418
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).
POBA or FDA-approved commercially available -limus eluting DES
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
Target Lesion Failure (TLF)
Time frame: 12 months post-index procedure
Device success
Time frame: Index Procedure
Lesion Success
Time frame: Index Procedure
Procedure Success
Time frame: Index Procedure
Composite Safety Endpoint
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
All-cause Mortality
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Cardiovascular Mortality
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
MI
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Clinically driven TLR, all TLR
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Clinically driven TVR, all TVR, non-TVR
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
TLF
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
TVF
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Stent Thrombosis
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Bleeding
Time frame: Prior to discharge, at 1, 6, and 12 months
Net adverse clinical events
Time frame: Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up
Binary angiographic restenosis
Time frame: 12 months
In-stent percent diameter stenosis
Time frame: 12 months
In-segment percent diameter stenosis
Time frame: 12 months
In-stent LLL
Time frame: 12 months
In-segment LLL
Time frame: 12 months
In-stent MLD
Time frame: 12 months
In-segment MLD
Time frame: 12 months
OCT assessment of neointimal hyperplasia, neo-atherosclerosis, and stent malapposition
Time frame: 12 months
TLF
SELUTION SLR 014 DEB versus DES among participants with one previous layer of stent
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 38 more locations