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PEPCAD III Substudy: Stem Cell Mobilization (PEPCADIIIsub)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00473499
First received: May 14, 2007
Last updated: June 29, 2010
Last verified: June 2010

May 14, 2007
June 29, 2010
July 2007
March 2009   (final data collection date for primary outcome measure)
  • stem cell mobilization and differentiation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • endothelial function [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • stem cell mobilization and differentiation [ Time Frame: 7 days ]
  • endothelial function [ Time Frame: 9 months ]
Complete list of historical versions of study NCT00473499 on ClinicalTrials.gov Archive Site
  • late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • late lumen loss [ Time Frame: 9 months ]
  • MACE [ Time Frame: 9 months ]
Not Provided
Not Provided
 
PEPCAD III Substudy: Stem Cell Mobilization
Paclitaxel-Eluting PTCA-Balloon in Combination With the Coroflex Blue Stent vs the Sirolimus Coated Cypher Stent in the Treatment of Advanced Coronary Artery Disease - Substudy Homburg/Saar

The aim of the PEPCAD III substudy is to assess the efficacy of the Paclitaxel-eluting DEBlue stent system in the treatment of stenoses in native coronary arteries compared to the Sirolimus-eluting Cypher stent by intravascular ultrasound (IVUS) and to study the influence of both devices on endothelial function, coronary flow reserve, and stem cell mobilization.

The aim of the PEPCAD III substudy is to assess the efficacy of the DEBlue® Paclitaxel-eluting stent system in the treatment of stenoses in native coronary arteries compared to the Sirolimus-eluting Cypher stent by intravascular ultrasound (IVUS) and to study the influence of both devices on endothelial function, coronary flow reserve, and stem cell mobilization. This study is a prospective, randomized, single-center, two-armed phase-II study. During the PEPCAD III trial, 40 patients of the Homburg / Saar center will be randomly assigned to ei-ther one of the treatment groups (20 patients treated with DEBlue, 20 patients with Cypher®). Patients with stable or selected forms of unstable angina or documented ischemia due to a significant lesion in a native coronary artery will be included. Vessels may not supply an en-tirely infarcted myocardial area. Additional 20 patients receiving uncoated stents (Coroflex® Blue, B.Braun) will undergo the same diagnostic procedures.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
Device: DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
  • Experimental: DEBlue stent
    Paclitaxel coated balloon with CoCr stent mounted on it
    Intervention: Device: DEBlue vs Cypher vs BMS
  • Active Comparator: Cypher stent
    Intervention: Device: DEBlue vs Cypher vs BMS
  • Placebo Comparator: Coroflex Blue stent
    Intervention: Device: DEBlue vs Cypher vs BMS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00473499
BBM-VS54-HOM
Yes
Prof. Dr. Bruno Scheller, University Hospital, Saarland
University Hospital, Saarland
Not Provided
Principal Investigator: Bruno Scheller Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany
University Hospital, Saarland
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP