At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Drug Coated Balloon Compared to Bare Metal Stent Using FFR-guidance for the Treatment of de Novo Coronary Artery Lesions
In Brief
A clinical study evaluating Drug Coated Balloon and Bare Metal Stent for Stable Angina and Unstable Angina. Completed, enrolled 40 participants across 1 site.
Detailed Summary
This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.
Study Details
Timeline
Interventions
If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.
BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.