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

R

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

Trial contacts and locations

1

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Central trial contact

Rudolf Berger, PD MD; Daniel Dalos, MD

Data sourced from clinicaltrials.gov

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