Late Acquired Malaposition and Different Polymers

December 26, 2013 updated by: Univ. Prof. Dr. Thomas Neunteufl, Medical University of Vienna

Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography

The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

please see brief summary

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

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
        • Medical University of Vienna

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES

Exclusion Criteria:

  • chronic renal failure (serum creatinine ≥ 2.5mg/dl)
  • restenotic lesions

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Everolimus-Eluting-Stent (EES)
Patients treated with EES
Procedure: Everolimus-Eluting Stent (EES)
Patients treated with EES
Active Comparator: Zotarolimus-Eluting-Stent (ZES)
Patients treated with ZES
Procedure: Zotarolimus-Eluting-Stent (ZES)
Patients treated with ZES
Active Comparator: Biolimus-Eluting-Stent (BES)
Patients treated with BES
Procedure: Biolimus-Eluting-Stent (BES)
Patients treated with BES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of stent struts with late acquired malaposition
Time Frame: 1 year after stent implantation
1 year after stent implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
number of stent struts with late acquired malaposition
Time Frame: 2 years after stent implantation
2 years after stent implantation

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Thomas Neunteufl, Prof. Dr., PI

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

October 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 26, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUW-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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