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SELUTION SLR™ 014 In-stent Restenosis — SELUTION4ISR  

Coronary Restenosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04280029
Study type Interventional
Source M.A. Med Alliance S.A.
Contact Michelle Alamo
Phone 267-218-2816
Email michelle.alamo@cordis.com
Status Recruiting
Phase N/A
Start date July 6, 2020
Completion date November 2027
View Details
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