DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease - Full Text View

Sponsor:	University Hospital, Saarland
Collaborator:	B.Braun Vascular Systems, Berlin, Germany
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00473772

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: DEBlue stent vs. Cypher stent	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:

late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MACE [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
MACE [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Binary restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	643
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2011
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cypher Stent	Device: DEBlue stent vs. Cypher stent DES vs. DEB with BMS
Experimental: DEBlue Stent	Device: DEBlue stent vs. Cypher stent DES vs. DEB with BMS

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473772

Locations

Belgium
Cardiovascular Center OLV Hospital Aalst
Aalst, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Czech Republic
Institute for Clinical and Experimental Medicine
Prague, Czech Republic
France
Clinique Saint Martin
Caen, France
Germany
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany, 66421
Kerckhoff-Clinic Bad Nauheim
Bad Nauheim, Germany, 61231
Kardiologie, Campus Virchow-Klinikum, Charite
Berlin, Germany, 13353
St. Johannes-Hospital
Dortmund, Germany
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
Freiburg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
University of Rostock
Rostock, Germany
Netherlands
Rihnstate Hospital
Arnhem, Netherlands
Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Sweden
Universitetssjukhuset Lund
Lund, Sweden
United Kingdom
Northern General Hospital
Sheffield, United Kingdom

Sponsors and Collaborators

University Hospital, Saarland

B.Braun Vascular Systems, Berlin, Germany

Investigators

Principal Investigator:	Bruno Scheller	University of Saarland - Internal Medicine III, Homburg/Saar, Germany
Principal Investigator:	Christian Hamm	Kerckhoff-Clinic Bad Nauheim, Germany

More Information

Publications:

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

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. Epub 2006 Nov 13.

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.

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. Epub 2004 Aug 9.

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. No abstract available.

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.

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.

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.

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.

Responsible Party:	Dr. Michael Boxberger, B.Braun Vascular Systems, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00473772 History of Changes
Other Study ID Numbers:	BBM-VS-54
Study First Received:	May 14, 2007
Last Updated:	February 19, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:

cobalt chromium stent
paclitaxel coated balloon catheter
DEBlue
drug eluting balloon

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel

Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 02, 2012