ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279006
Recruitment Status : Unknown
Verified January 2006 by Foundation for Cardiovascular Research, Zurich.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2006
Last Update Posted : January 19, 2006
Sponsor:
Information provided by:
Foundation for Cardiovascular Research, Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Percutaneous coronary intervention Not Applicable

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  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Study Start Date : January 2006
Study Completion Date : March 2007



Primary Outcome Measures :
  1. In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
  2. 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279006


Contacts
Contact: Marco Roffi, MD +41 44 255 8573 marco.roffi@usz.ch

Sponsors and Collaborators
Foundation for Cardiovascular Research, Zurich
Investigators
Study Director: Franz R Eberli, MD University Hospital, Zürich

ClinicalTrials.gov Identifier: NCT00279006     History of Changes
Other Study ID Numbers: EK-12006
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: January 19, 2006
Last Verified: January 2006

Keywords provided by Foundation for Cardiovascular Research, Zurich:
DES (drug eluting stents)
CAD (cornary artery disease)
stent retrieval

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases