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PEPCAD III Substudy: Stem Cell Mobilization (PEPCADIIIsub)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
DEBlue vs Cypher vs BMS
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug eluting balloon, drug eluting stent, stem cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

DEBlue stent

Cypher stent

Coroflex Blue stent

Arm Description

Paclitaxel coated balloon with CoCr stent mounted on it

Outcomes

Primary Outcome Measures

stem cell mobilization and differentiation
endothelial function

Secondary Outcome Measures

late lumen loss
MACE

Full Information

First Posted
May 14, 2007
Last Updated
June 29, 2010
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT00473499
Brief Title
PEPCAD III Substudy: Stem Cell Mobilization
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug eluting balloon, drug eluting stent, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEBlue stent
Arm Type
Experimental
Arm Description
Paclitaxel coated balloon with CoCr stent mounted on it
Arm Title
Cypher stent
Arm Type
Active Comparator
Arm Title
Coroflex Blue stent
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
DEBlue vs Cypher vs BMS
Intervention Description
BMS vs DES vs DEB+BMS
Primary Outcome Measure Information:
Title
stem cell mobilization and differentiation
Time Frame
7 days
Title
endothelial function
Time Frame
9 months
Secondary Outcome Measure Information:
Title
late lumen loss
Time Frame
9 months
Title
MACE
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Scheller
Organizational Affiliation
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
City
Homburg / Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17435062
Citation
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.
Results Reference
background
PubMed Identifier
17101615
Citation
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.
Results Reference
background
PubMed Identifier
16864669
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. doi: 10.1148/radiol.2402051248.
Results Reference
background
PubMed Identifier
15302790
Citation
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.
Results Reference
background
PubMed Identifier
17261663
Citation
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.
Results Reference
background
PubMed Identifier
23996969
Citation
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.
Results Reference
derived

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PEPCAD III Substudy: Stem Cell Mobilization

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