DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease (PEPCADIII)

University Hospital, Saarland

Status and phase

Completed

Phase 2

Phase 1

Conditions

Coronary Artery Disease

Treatments

Device: DEBlue stent vs. Cypher stent

Study type

Interventional

Funder types

Other

Identifiers

NCT00473772

BBM-VS-54

Details and patient eligibility

About

The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.

Full description

The incidence of in-stent restenosis after percutaneous coronary intervention varies between 5 and 35% after bare metal stenting and is as high as 19% after the implantation of a drug-eluting stent in patients at moderate risk. Restenosis due to neointimal hyperplasia is a slow process, suggesting that therapeutic local drug administration would need to be prolonged to be beneficial. Stent-based local drug delivery provides sustained drug release using special release technologies like polymer coating. However, cell culture experiments indicate that even brief contact between vascular smooth muscle cells and lipophilic taxane compounds can inhibit vascular smooth muscle cell proliferation for a long period. In experiments in swine, intracoronary delivery of paclitaxel by contrast media or by a drug-coated balloon catheter was found to result in vascular tissue concentrations capable of producing antiproliferative effects, thus leading to a significant reduction in neointimal proliferation. In these animal studies, the most pronounced reduction of neointimal formation was seen with paclitaxel-coated balloon catheters.

Enrollment

643 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
Patients must be ≥ 18 years of age
Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 9 months follow-up
Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
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.
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
Chronic total occlusions
Pregnancy
Patients with stand alone balloon angioplasty, or stent deployment 6 months prior to enrolment into this study