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. - PEPCAD III

B. Braun Melsungen AG Vascular Systems0 个研究点目标入组 75 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•* 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

•* 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

发起方

B. Braun Melsungen AG Vascular Systems