NCT02868203

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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)

Conditions

• Angina, Unstable
• Non-ST-Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	OCT	OCT after stent implantation
DEVICE	eLuting stent

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-08-01
• Completion: 2020-08-01
• First posted: 2016-08-16
• Last updated: 2016-08-16