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

November 27, 2013 updated by: Rudolf Berger
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Rudolf Berger, PD MD
        • Sub-Investigator:
          • Daniel Dalos, MD
        • Sub-Investigator:
          • Clemens Gangl, MD
        • Sub-Investigator:
          • Christian Roth, MD
        • Sub-Investigator:
          • Thomas Neunteufl, Prof. MD
        • Sub-Investigator:
          • Georg Delle-Karth, Prof. MD
        • Sub-Investigator:
          • Irene Lang, Prof. MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease

Description

Inclusion Criteria for implanting an Absorb scaffold:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse post-stenting results
Time Frame: 1 year
Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rudolf Berger

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Absorb/Xience 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bioresorbable Scaffolds

Clinical Trials on Absorb scaffold

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe