PEPCAD III Substudy: Stem Cell Mobilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DEBlue vs Cypher vs BMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEBlue stent<br>Paclitaxel coated balloon with CoCr stent mounted on it | Device: DEBlue vs Cypher vs BMS<br>* BMS vs DES vs DEB+BMS<br>|
| Active Comparator: Cypher stent<br> | Device: DEBlue vs Cypher vs BMS<br>* BMS vs DES vs DEB+BMS<br>|
| Placebo Comparator: Coroflex Blue stent<br> | Device: DEBlue vs Cypher vs BMS<br>* BMS vs DES vs DEB+BMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stem cell mobilization and differentiation |  | 7 days | 
| endothelial function |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss |  | 9 months | 
| MACE |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon, drug eluting stent, stem cells