Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison

January 17, 2006 updated by: Foundation for Cardiovascular Research, Zurich
This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the coronary artery with respect to the complications that may occur in case it becomes necessary to retract the stent during the intervention. It has been noted that stents carrying a drug for local application may be more difficult to retract than the more smooth bare metal stents.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients in whom DES implantation is planned will be randomized to one of the 3 commercially available stents (i.e., Cypher, Taxus-Liberté, Endeavor).

Sealed envelopes will be used for randomization purposes. Should additional stents be required in the same patient for the same or other lesions, another stent of the same type of stents will be implanted.

The following assessments will be made:

  • Unblinded subjective operator assessment based on a questionnaire. The questionnaire will include questions on problems encountered during stent-balloon retrieval, special maneuvers performed (e.g., retrieval of the catheter during device removal, and possible complications associated with device retrieval).

  • Blinded measurements of following parameters:

    1. Minimal and maximal distance between the tip of the guiding catheter and the proximal stent end during stent-balloon retrieval.
    2. Minimal and maximal distance between the tip of the guidewire and the distal portion of the stent during stent-balloon retrieval.
    3. To do so the retrieval of the stent-balloon will be documented on ciné-angiography. The measurements will be performed by a qualified technician/physician blinded to the type of device used.

  • Clinical endpoints:

    d. In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.

    e. Myocardial infarction defined as creatine kinase MB-isoform [CK-MB] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.

  • Target enrollment of 150 patients

Study Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

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

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a planned angiography and percutane coronary intervention
  • Age 18 years or above
  • Informed consent to PCI and to participation in this trial

Exclusion Criteria:

  • Patients who after angiography are deemed not suitable for stent implant (operators discretion)

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
Myocardial infarction defined as creatine kinase MB-isoform [CK-MB] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.

Collaborators and Investigators

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

Sponsor

Foundation for Cardiovascular Research, Zurich

Investigators

  • Study Director: Franz R Eberli, MD, University Hospital, Zürich

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

January 1, 2006

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 19, 2006

Last Update Submitted That Met QC Criteria

January 17, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-12006

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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