Status:
COMPLETED
PEPCAD III Substudy: Stem Cell Mobilization
Lead Sponsor:
University Hospital, Saarland
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 Cy...
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 C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00473499
Start Date
July 1 2007
End Date
November 1 2009
Last Update
June 30 2010
Active Locations (1)
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1
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany, 66421