Clinical trial NCT00279006: Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Official title: Adhesiveness of Coronary Drug-Eluting Stents to the Delivery Balloon-Catheter: A Randomized Comparison
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: DES (drug eluting stents)
CAD (cornary artery disease)
stent retrieval
Lead sponsor: Foundation for Cardiovascular Research, Zurich
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Zürich
name: Franz R Eberli, MD
role: STUDY_DIRECTOR
References: