PEPCAD III Substudy: Stem Cell Mobilization

Coronary Artery Disease Clinical Trial

— PEPCADIIIsub  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473499
• Other study ID #: BBM-VS54-HOM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 14, 2007
• Last updated: June 29, 2010
• Start date: July 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2010
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 Cypher stent by intravascular ultrasound (IVUS) and to study the influence of both devices on endothelial function, coronary flow reserve, and stem cell mobilization.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS

Locations

Country	Name	City	State
Germany	Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes	Homburg / Saar	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. Epub 2007 Jan 29. — View Citation

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm 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. Epub 2006 Nov 13. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9. — View Citation

Scheller B, Speck U, Böhm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stem cell mobilization and differentiation		7 days	No
Primary	endothelial function		9 months	No
Secondary	late lumen loss		9 months	No
Secondary	MACE		9 months	Yes