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

NCT00473772 | Completed Phase 1 DMC

• 1 other identifier: BBM-VS-54
• Study Type: interventional
• Target: 643
• Locations: 8 countries
• Sites: 16

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.

Conditions

Coronary Artery Disease

Keywords

cobalt chromium stent; paclitaxel coated balloon catheter; DEBlue; drug eluting balloon

Outcome Measures

Primary Outcomes (1)

• late lumen loss

  9 months

Secondary Outcomes (4)

• MACE

  9 months

• MACE

  3 years

• MACE

  30 days

• Binary restenosis rate

  9 months

Study Arms (2)

Cypher Stent

ACTIVE COMPARATOR

Device: DEBlue stent vs. Cypher stent

DEBlue Stent

EXPERIMENTAL

Device: DEBlue stent vs. Cypher stent

Interventions

DEBlue stent vs. Cypher stent DEVICE

DES vs. DEB with BMS

Cypher Stent; DEBlue Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead
• B.Braun Vascular Systems, Berlin, Germany: collaborator

Study Sites (16)

Cardiovascular Center OLV Hospital Aalst

Aalst, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Institute for Clinical and Experimental Medicine

Prague, Czechia

Location

Clinique Saint Martin

Caen, France

Location

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg / Saar, Saarland, 66421, Germany

Location

Kerckhoff-Clinic Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Kardiologie, Campus Virchow-Klinikum, Charite

Berlin, 13353, Germany

Location

St. Johannes-Hospital

Dortmund, Germany

Location

Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

University of Rostock

Rostock, Germany

Location

Rihnstate Hospital

Arnhem, Netherlands

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Location

Universitetssjukhuset Lund

Lund, Sweden

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 17435062 BACKGROUND

• 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.

  PMID: 17101615 BACKGROUND

• 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.

  PMID: 16864669 BACKGROUND

• 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.

  PMID: 15302790 BACKGROUND

• 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.

  PMID: 16106539 BACKGROUND

• 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.

  PMID: 15076010 BACKGROUND

• 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.

  PMID: 14563585 BACKGROUND

• 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.

  PMID: 12909076 BACKGROUND

• 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.

  PMID: 11753151 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bruno Scheller

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

  PRINCIPAL INVESTIGATOR

• Christian Hamm

  Kerckhoff-Clinic Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2011
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

FR (1); DE (8); SE (1); BE (2); GB (1); ES (1); CZ (1); NL (1)