Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study

• Conditions: Bioresorbable Scaffolds
• Interventions: Device: Absorb scaffold; Device: Xience stent

• Registration Number: NCT02001025
• Lead Sponsor: Rudolf Berger

Brief Summary

The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Last Update Submitted: 2013-11-27
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Absorb scaffold	Absorb scaffold	Bioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years
Xience stent	Xience stent	Second generation drug-eluting stent to treat coronary artery lesions

Primary Outcome Measures

Name	Time	Method
adverse post-stenting results	1 year	Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria