Paclitaxel-Eluting PTCA-Balloon in Combination with the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease Clnical investigational plan, version 18, 16 october 2006.

Phase 3

Conditions: Artherosclerotic cornonary artery disease
10011082

Registration Number: NL-OMON31372

Lead Sponsor: B. Braun Melsungen AG Vascular Systems

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

* Patients with stable or unstable angina or documented ischemia due to a
significant lesion in a native coronary artery
* Patients eligible for coronary revascularization by means of PCI
* Intention to treat one lesion with one stent
* Patients must be * 18 years of age
* Patients must agree to undergo the 9 months angiographic follow-up
* Patients must agree to undergo the 1 and 3 year clinical follow-up
* Patient is able to verbally acknowledge an understanding of the associated risks,
benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon
angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in
combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM
stent. The patients, by providing informed consent, agree to these risks and
benefits as stated in the patient informed consent document.
Inclusion Criteria: Lesion Related
* Significant stenoses in native coronary arteries with nominal stent diameters
between * 2.5 mm and * 3.5 mm and < 24 mm in length

Exclusion Criteria

* Unprotected left main
* In stent restenosis
* Indication for more than one lesion to treat, even as staged procedure
* Intended bifurcational stenting
* Patients requiring chronic anticoagulation
* SVG and AG
* Acute MI (STEMI, NSTEMI)
* Cardiogenic shock
* Chronical total occlusions
* Pregnancy
* Patients with stand alone balloon angioplasty, or stent deployment 6 months prior
to enrolment into this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint :<br /><br>Late lumen loss at 9 months. A deviation of +/- 3 months to the 9<br /><br>months FU is accepted.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Procedural success<br /><br>30-day complication rate (by phone)<br /><br>Percent stenosis at 9 months<br /><br>Angiographic binary restenosis rate at 9 months<br /><br>Acute and cumulative MACE rate at 9 months<br /><br>Cumulative MACE rate after one years<br /><br>Cumulative MACE rate after three years<br /><br>Indication for premature follow-up</p><br>