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

NCT ID: NCT00473772

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 643 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-01-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cypher Stent

Group Type: ACTIVE_COMPARATOR

DEBlue stent vs. Cypher stent

Intervention Type: DEVICE

DES vs. DEB with BMS

DEBlue Stent

Group Type: EXPERIMENTAL

DEBlue stent vs. Cypher stent

Intervention Type: DEVICE

DES vs. DEB with BMS

Interventions

DEBlue stent vs. Cypher stent

DES vs. DEB with BMS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.Braun Vascular Systems, Berlin, Germany

UNKNOWN

Sponsor Role: collaborator

University Hospital, Saarland

OTHER

Sponsor Role: lead

Responsible Party

B.Braun Vascular Systems, Berlin, Germany

Principal Investigators

Bruno Scheller

Role: PRINCIPAL_INVESTIGATOR

University of Saarland - Internal Medicine III, Homburg/Saar, Germany

Christian Hamm

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff-Clinic Bad Nauheim, Germany

Locations

Cardiovascular Center OLV Hospital Aalst

Aalst, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Clinique Saint Martin

Caen, , France

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg / Saar, Saarland, Germany

Kerckhoff-Clinic Bad Nauheim

Bad Nauheim, , Germany

Kardiologie, Campus Virchow-Klinikum, Charite

Berlin, , Germany

St. Johannes-Hospital

Dortmund, , Germany

Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

Freiburg im Breisgau, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Klinikum Ludwigshafen

Ludwigshafen, , Germany

University of Rostock

Rostock, , Germany

Rihnstate Hospital

Arnhem, , Netherlands

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Universitetssjukhuset Lund

Lund, , Sweden

Northern General Hospital

Sheffield, , United Kingdom

Countries

Belgium; Czechia; France; Germany; Netherlands; Spain; Sweden; United Kingdom

References

Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.

Reference Type: BACKGROUND

PMID: 17435062 (View on PubMed)

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

Reference Type: BACKGROUND

PMID: 17101615 (View on PubMed)

Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.

Reference Type: BACKGROUND

PMID: 16864669 (View on PubMed)

Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

Reference Type: BACKGROUND

PMID: 15302790 (View on PubMed)

Speck U, Scheller B, Abramjuk C, Bernhardt U. Drug delivery by angiographic contrast media: inhibition of restenosis. Acad Radiol. 2005 May;12 Suppl 1:S14-7. doi: 10.1016/j.acra.2005.02.017. No abstract available.

Reference Type: BACKGROUND

PMID: 16106539 (View on PubMed)

Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.

Reference Type: BACKGROUND

PMID: 15076010 (View on PubMed)

Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.

Reference Type: BACKGROUND

PMID: 14563585 (View on PubMed)

Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. doi: 10.1016/s0195-668x(03)00317-8.

Reference Type: BACKGROUND

PMID: 12909076 (View on PubMed)

Scheller B, Speck U, Schmitt A, Clauss W, Sovak M, Bohm M, Stoll HP. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Invest Radiol. 2002 Jan;37(1):29-34. doi: 10.1097/00004424-200201000-00006.

Reference Type: BACKGROUND

PMID: 11753151 (View on PubMed)

Other Identifiers

BBM-VS-54

Identifier Type: -

Identifier Source: org_study_id