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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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: DEBlue vs Cypher vs BMS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2007
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DEBlue stent
Paclitaxel coated balloon with CoCr stent mounted on it
Device: DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Active Comparator: Cypher stent Device: DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Placebo Comparator: Coroflex Blue stent Device: DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473499

Locations
Germany
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Bruno Scheller Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Bruno Scheller, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00473499     History of Changes
Other Study ID Numbers: BBM-VS54-HOM
Study First Received: May 14, 2007
Last Updated: June 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
drug eluting balloon
drug eluting stent
stem cells

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014