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

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: DEBlue stent vs. Cypher stent

• Registration Number: NCT00473772
• Lead Sponsor: University Hospital, Saarland

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Study Start: 2007-07
• Primary Completion: 2008-10
• Study Completion: 2011-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cypher Stent	DEBlue stent vs. Cypher stent	-
DEBlue Stent	DEBlue stent vs. Cypher stent	-

Primary Outcome Measures

Name	Time	Method
late lumen loss	9 months

Secondary Outcome Measures

Name	Time	Method
MACE	30 days
Binary restenosis rate	9 months

Trial Locations

Locations (16)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czech Republic

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes; 🇩🇪 Homburg / Saar, Saarland, Germany

Cardiovascular Center OLV Hospital Aalst; 🇧🇪 Aalst, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Kardiologie, Campus Virchow-Klinikum, Charite; 🇩🇪 Berlin, Germany

Clinique Saint Martin; 🇫🇷 Caen, France

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

University of Rostock; 🇩🇪 Rostock, Germany

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

St. Johannes-Hospital; 🇩🇪 Dortmund, Germany

Kerckhoff-Clinic Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

Rihnstate Hospital; 🇳🇱 Arnhem, Netherlands

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Universitetssjukhuset Lund; 🇸🇪 Lund, Sweden

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie; 🇩🇪 Freiburg, Germany