Clinical trial NCT00473772: DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Keywords: cobalt chromium stent
paclitaxel coated balloon catheter
DEBlue
drug eluting balloon
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: B.Braun Vascular Systems, Berlin, Germany
First posted: 2007-05-15
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: MACE
timeFrame: 9 months
measure: MACE
timeFrame: 3 years
measure: MACE
timeFrame: 30 days
measure: Binary restenosis rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Cardiovascular Center OLV Hospital Aalst
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Prague
country: Czech Republic
facility: Institute for Clinical and Experimental Medicine
city: Caen
country: France
facility: Clinique Saint Martin
city: Homburg / Saar
country: Germany
facility: Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
state: Saarland
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Clinic Bad Nauheim
city: Berlin
country: Germany
facility: Kardiologie, Campus Virchow-Klinikum, Charite
city: Dortmund
country: Germany
facility: St. Johannes-Hospital
city: Freiburg
country: Germany
facility: Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Rostock
country: Germany
facility: University of Rostock
city: Arnhem
country: Netherlands
facility: Rihnstate Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Lund
country: Sweden
facility: Universitetssjukhuset Lund
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: University of Saarland - Internal Medicine III, Homburg/Saar, Germany
name: Bruno Scheller
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerckhoff-Clinic Bad Nauheim, Germany
name: Christian Hamm
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.