Clinical Trial: Drug Eluting Balloon for Treatment of Unstable Angina

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina

Brief Summary: This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.

Detailed Summary: Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
Sponsor: Yun Dai Chen

Current Primary Outcome: Changes in Target Lumen assessed by optical coherence tomography [ Time Frame: 12 months ]

A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence rate of MACE [ Time Frame: Incidence rate of MACE from baseline to 12 months ]

MACE include composite of death, myocardial infarction, or target-vessel revascularization


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: February 29, 2016
Date Started: November 2015
Date Completion: August 2017
Last Updated: March 25, 2017
Last Verified: September 2016