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

May 5, 2014 updated by: University Hospital, Saarland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

643

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
late lumen loss
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Binary restenosis rate
Time Frame: 9 months
9 months
MACE
Time Frame: 9 months
9 months
MACE
Time Frame: 3 years
3 years
MACE
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBM-VS-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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