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Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

Coronary Artery Disease Clinical Trial

Official title:
A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions

Clinical Trial Summary

This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.

Clinical Trial Description

Patients with true coronary bifurcation lesions (Medina [1, 1, 1] or [0, 1, 1]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05200637
Study type Interventional
Source Chang Gung Memorial Hospital
Contact Ying-Chang Tung, MD
Phone 886-3-3281200
Email n12374@cgmh.org.tw
Status Not yet recruiting
Phase N/A
Start date February 1, 2022
Completion date December 31, 2024
View Details
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