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

NCT ID: NCT02001025

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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Conditions

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Bioresorbable Scaffolds

Keywords

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coronary vessels coronary stenosis percutaneous transluminal angioplasty stents drug-eluting stents bioresorbable scaffolds optical coherence tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Absorb scaffold

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

Absorb scaffold

Intervention Type DEVICE

Xience stent

Second generation drug-eluting stent to treat coronary artery lesions

Xience stent

Intervention Type DEVICE

Interventions

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Absorb scaffold

Intervention Type DEVICE

Xience stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age \< 55 years OR
* lesion length \> 24mm OR
* multiple lesions to be treated
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rudolf Berger

OTHER

Sponsor Role lead

Responsible Party

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Rudolf Berger

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Daniel Dalos, MD

Role: CONTACT

Phone: +43 1 40400 4614

Email: [email protected]

Rudolf Berger, PD MD

Role: CONTACT

Phone: +43 1 40400 4614

Email: [email protected]

Facility Contacts

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Rudolf Berger, PD MD

Role: primary

Other Identifiers

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Absorb/Xience 01

Identifier Type: -

Identifier Source: org_study_id