Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedDecember 4, 2013
November 1, 2013
1.1 years
November 27, 2013
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adverse post-stenting results
Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT)
1 year
Study Arms (2)
Absorb scaffold
Bioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years
Xience stent
Second generation drug-eluting stent to treat coronary artery lesions
Interventions
Eligibility Criteria
Patients with coronary artery disease
You may qualify if:
- age \< 55 years OR
- lesion length \> 24mm OR
- multiple lesions to be treated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rudolf Bergerlead
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2014
Last Updated
December 4, 2013
Record last verified: 2013-11