- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473499
PEPCAD III Substudy: Stem Cell Mobilization (PEPCADIIIsub)
June 29, 2010 updated by: University Hospital, Saarland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
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
-
-
Saarland
-
Homburg / Saar, Saarland, Germany, 66421
- Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
-
-
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 |
---|---|
Experimental: DEBlue stent
Paclitaxel coated balloon with CoCr stent mounted on it
|
BMS vs DES vs DEB+BMS
|
Active Comparator: Cypher stent
|
BMS vs DES vs DEB+BMS
|
Placebo Comparator: Coroflex Blue stent
|
BMS vs DES vs DEB+BMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
stem cell mobilization and differentiation
Time Frame: 7 days
|
7 days
|
endothelial function
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
late lumen loss
Time Frame: 9 months
|
9 months
|
MACE
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Scheller, Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, 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
- 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.
- 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.
- 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.
- 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.
- Inoue T, Sata M, Hikichi Y, Sohma R, Fukuda D, Uchida T, Shimizu M, Komoda H, Node K. Mobilization of CD34-positive bone marrow-derived cells after coronary stent implantation: impact on restenosis. Circulation. 2007 Feb 6;115(5):553-61. doi: 10.1161/CIRCULATIONAHA.106.621714. Epub 2007 Jan 29.
- Clever YP, Cremers B, Speck U, Dietz U, Bohm M, Scheller B. Influence of a paclitaxel coated balloon in combination with a bare metal stent on restenosis and endothelial function: comparison with a drug eluting stent and a bare metal stent. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):323-31. doi: 10.1002/ccd.25184. Epub 2013 Sep 30.
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)
March 1, 2009
Study Completion (Actual)
November 1, 2009
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)
June 30, 2010
Last Update Submitted That Met QC Criteria
June 29, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBM-VS54-HOM
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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