Clinical Trial: OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome (NSTE ACS)

Brief Summary: This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome

Detailed Summary: Major concerns were addressed to the delayed healing process of drug-eluting stents . To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following CordimaxTM stent implantation, in patients with non-ST elevation acute coronary syndrome . Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points (3-6-12 Months)
Sponsor: Xijing Hospital

Current Primary Outcome: Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT [ Time Frame: 12 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Xijing Hospital

Dates:
Date Received: August 11, 2016
Date Started: August 2016
Date Completion: August 2020
Last Updated: August 15, 2016
Last Verified: May 2016