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

Rudolf Berger

Status: Unknown

Conditions: Bioresorbable Scaffolds

Treatments: Device: Absorb scaffold; Device: Xience stent

Study type: Observational

Funder types: Other

Identifiers

NCT02001025

Absorb/Xience 01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for implanting an Absorb scaffold:

• age < 55 years OR
• lesion length > 24mm OR
• multiple lesions to be treated

Trial design

60 participants in 2 patient groups

Absorb scaffold

Description:

Bioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years

Treatment:

Device: Absorb scaffold

Xience stent

Description:

Second generation drug-eluting stent to treat coronary artery lesions

Treatment:

Device: Xience stent