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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DEBlue stent vs. Cypher stent
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cobalt chromium stent, paclitaxel coated balloon catheter, DEBlue, drug eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Center OLV Hospital Aalst
  • Ziekenhuis Oost-Limburg
  • Institute for Clinical and Experimental Medicine
  • Clinique Saint Martin
  • Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
  • Kerckhoff-Clinic Bad Nauheim
  • Kardiologie, Campus Virchow-Klinikum, Charite
  • St. Johannes-Hospital
  • Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
  • Medizinische Hochschule Hannover
  • Klinikum Ludwigshafen
  • University of Rostock
  • Rihnstate Hospital
  • Hospital Universitari Germans Trias I Pujol
  • Universitetssjukhuset Lund
  • Northern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cypher Stent

DEBlue Stent

Arm Description

Outcomes

Primary Outcome Measures

late lumen loss

Secondary Outcome Measures

MACE
MACE
MACE
Binary restenosis rate

Full Information

First Posted
May 14, 2007
Last Updated
May 5, 2014
Sponsor
University Hospital, Saarland
Collaborators
B.Braun Vascular Systems, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00473772
Brief Title
DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Saarland
Collaborators
B.Braun Vascular Systems, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
cobalt chromium stent, paclitaxel coated balloon catheter, DEBlue, drug eluting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cypher Stent
Arm Type
Active Comparator
Arm Title
DEBlue Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DEBlue stent vs. Cypher stent
Intervention Description
DES vs. DEB with BMS
Primary Outcome Measure Information:
Title
late lumen loss
Time Frame
9 months
Secondary Outcome Measure Information:
Title
MACE
Time Frame
9 months
Title
MACE
Time Frame
3 years
Title
MACE
Time Frame
30 days
Title
Binary restenosis rate
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Scheller
Organizational Affiliation
University of Saarland - Internal Medicine III, Homburg/Saar, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Hamm
Organizational Affiliation
Kerckhoff-Clinic Bad Nauheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center OLV Hospital Aalst
City
Aalst
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
Country
Czech Republic
Facility Name
Clinique Saint Martin
City
Caen
Country
France
Facility Name
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
City
Homburg / Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Kerckhoff-Clinic Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Kardiologie, Campus Virchow-Klinikum, Charite
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
St. Johannes-Hospital
City
Dortmund
Country
Germany
Facility Name
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
Country
Germany
Facility Name
University of Rostock
City
Rostock
Country
Germany
Facility Name
Rihnstate Hospital
City
Arnhem
Country
Netherlands
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
Country
Spain
Facility Name
Universitetssjukhuset Lund
City
Lund
Country
Sweden
Facility Name
Northern General Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17435062
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.
Results Reference
background
PubMed Identifier
17101615
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.
Results Reference
background
PubMed Identifier
16864669
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.
Results Reference
background
PubMed Identifier
15302790
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.
Results Reference
background
PubMed Identifier
16106539
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.
Results Reference
background
PubMed Identifier
15076010
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.
Results Reference
background
PubMed Identifier
14563585
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.
Results Reference
background
PubMed Identifier
12909076
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.
Results Reference
background
PubMed Identifier
11753151
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.
Results Reference
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DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

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