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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00279006
• Other study ID #: EK-12006
• Status: Not yet recruiting
• Phase: N/A
• First received: January 17, 2006
• Last updated: January 17, 2006
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2006
• Source: Foundation for Cardiovascular Research, Zurich
• Contact: Marco Roffi, MD
• Phone: +41 44 255 8573
• Email: marco.roffi[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Cardiovascular Research, Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
Primary	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.