NCT00473499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 coronary-artery-disease

Timeline
Completed

Started Jul 2007

Typical duration for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 30, 2010

Status Verified

June 1, 2010

Enrollment Period

1.7 years

First QC Date

May 14, 2007

Last Update Submit

June 29, 2010

Conditions

Coronary Artery Disease

Keywords

drug eluting balloondrug eluting stentstem cells

Outcome Measures

Primary Outcomes (2)

  • stem cell mobilization and differentiation

    7 days

  • endothelial function

    9 months

Secondary Outcomes (2)

  • late lumen loss

    9 months

  • MACE

    9 months

Study Arms (3)

DEBlue stent

EXPERIMENTAL

Paclitaxel coated balloon with CoCr stent mounted on it

Device: DEBlue vs Cypher vs BMS

Cypher stent

ACTIVE COMPARATOR
Device: DEBlue vs Cypher vs BMS

Coroflex Blue stent

PLACEBO COMPARATOR
Device: DEBlue vs Cypher vs BMS

Interventions

DEBlue vs Cypher vs BMSDEVICE

BMS vs DES vs DEB+BMS

Coroflex Blue stentCypher stentDEBlue stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes

Homburg / Saar, Saarland, 66421, Germany

Location

Related Publications (6)

  • 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.

    PMID: 17435062BACKGROUND

  • 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.

    PMID: 17101615BACKGROUND

  • 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.

    PMID: 16864669BACKGROUND

  • 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.

    PMID: 15302790BACKGROUND

  • 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.

    PMID: 17261663BACKGROUND

  • 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.

    PMID: 23996969DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bruno Scheller

    Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

June 30, 2010

Record last verified: 2010-06

Locations

DE(1)