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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Foundation for Cardiovascular Research, Zurich.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Foundation for Cardiovascular Research, Zurich
ClinicalTrials.gov Identifier:
NCT00279006
First received: January 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison

Further study details as provided by Foundation for Cardiovascular Research, Zurich:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: March 2007
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279006     History of Changes
Other Study ID Numbers: EK-12006
Study First Received: January 17, 2006
Last Updated: January 17, 2006
Health Authority: Switzerland: Swissmedic

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014