Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
392

Summary

Conditions
Coronary Restenosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomised controlled trialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal or drug-eluting coronary stent and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria to achieve a maximum of 418 randomized s...

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal or drug-eluting coronary stent and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria to achieve a maximum of 418 randomized subjects (includes 5% allowance for loss to follow-up). Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 20% of patients randomized to SOC will be treated with BA. Randomization will be stratified by DES or bare-metal stent (BMS) ISR and whether there has been previous repeat stenting of target lesion. Subjects with > 2 previous repeat stent procedures involving the target lesion will be excluded. The study will test for noninferiority of DEB versus SOC and additionally noninferiority of DEB vs DES. Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up. After initial randomized treatment subjects in the SOC group may receive DEB (including SELUTION SLR™) treatment for recurrent clinical restenosis requiring a repeat target lesion revascularization (TLR) (i.e. after the study primary endpoint has been failed). A subset of subjects (120 subjects including the first 60 randomized in the United States (US) and first 60 randomized in Europe who receive successful study treatment) will undergo planned angiographic follow-up at 12-13 months after completion of primary endpoint clinical follow-up/assessment. At 12-13 months, and after clinical primary endpoint has been assessed, a subset of the angiographic follow-up cohort (~60) will also undergo planned optical coherence tomography (OCT) follow-up, 30 United States (US) and 30 Europe.

Tracking Information

NCT #
NCT04280029
Collaborators
  • Genae
  • Baim Institute for Clinical Research
Investigators
Not Provided