Vascular Healing After BVS-implantation

Completed

• Conditions: Coronary Heart Disease
• Interventions: Device: Absorb-BVS

• Registration Number: NCT03079934
• Lead Sponsor: LMU Klinikum

Brief Summary

Evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging.

In addition long-term clinical follow-ups are planned for all patients treated with Absorb in the institution

Detailed Description

OCT-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. These results will be analysed in terms of clinical presentation, gender and age.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2016-03-11
• Primary Completion: 2016-07
• Study Completion: 2016-09-20
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• optical coherence tomography examination after BVS-implantation

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Absorb-BVS	Absorb-BVS	Bioresorbable vascular scaffold implantation

Primary Outcome Measures

Name	Time	Method
the amount of tissue coverage per strut level analysis at OCT	7 weeks	according to study protocol

Secondary Outcome Measures

Name	Time	Method
healing score in OCT examination	24 months	according to study protocol
amount of diameter stenosis per strut in OCT examination	24 months	according to study protocol
proportion of malapposed and protruding struts per stent in OCT examination	24 months	according to study protocol

Trial Locations

Locations (1)

Munich University Clinic; 🇩🇪 Munich, Bavarian, Germany