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

Coronary Artery Disease Clinical Trial

— PEPCADIII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473772
• Other study ID #: BBM-VS-54
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 14, 2007
• Last updated: May 5, 2014
• Start date: July 2007
• Est. completion date: January 2011

Study information

• Verified date: May 2014
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: January 2011
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DEBlue stent vs. Cypher stent
DES vs. DEB with BMS

Locations

Country	Name	City	State
Belgium	Cardiovascular Center OLV Hospital Aalst	Aalst
Belgium	Ziekenhuis Oost-Limburg	Genk
Czech Republic	Institute for Clinical and Experimental Medicine	Prague
France	Clinique Saint Martin	Caen
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
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes	Homburg / Saar	Saarland
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	University of Rostock	Rostock
Netherlands	Rihnstate Hospital	Arnhem
Spain	Hospital Universitari Germans Trias I Pujol	Badalona
Sweden	Universitetssjukhuset Lund	Lund
United Kingdom	Northern General Hospital	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Saarland	B.Braun Vascular Systems, Berlin, Germany

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Germany,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & Publications (9)

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm 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. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm 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. — View Citation

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

Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Böhm 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. — View Citation

Scheller B, Speck U, Schmitt A, Böhm 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. — View Citation

Scheller B, Speck U, Schmitt A, Clauss W, Sovak M, Böhm 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss		9 months	No
Secondary	MACE		9 months	Yes
Secondary	MACE		3 years	Yes
Secondary	MACE		30 days	Yes
Secondary	Binary restenosis rate		9 months	Yes