The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions (PEPCAD-CTO)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

B. Braun Melsungen AG

Information provided by:

University of Ulm

ClinicalTrials.gov Identifier:

NCT00670436

First received: April 29, 2008

Last updated: August 23, 2010

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 29, 2008

Last Updated Date

August 23, 2010

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Late loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00670436 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

percent diameter stenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
binary angiographic restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
late loss index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Target lumen revascularization [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
target vessel revascularization [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
major adverse cardiac events [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Official Title ^ICMJE

The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

Brief Summary

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Chronic Total Occlusion
Native Coronary Artery

Intervention ^ICMJE

Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
Other Names:
- SeQuent Please
- paclitaxel eluting balloon
Device: paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

Study Arm (s)

Active Comparator: A 1
paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery

Intervention: Device: paclitaxel eluting PTCA balloon catheter (SeQuent Please)
Active Comparator: A2
historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)

Intervention: Device: paclitaxel eluting Taxus stent (Boston Scientific)

Publications *

Wöhrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

chronic total occlusion
Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
occlusion in native coronary artery
indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
reference diameter 2.5 mm to 4.0 mm

Exclusion Criteria:

saphenous vein graft
bifurcation lesion with need to stent main and side branch
left main occlusion
de-novo stenosis (no occlusion)
restenosis
in-stent restenosis
contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
coronary aneurysm at target lesion

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00670436

Other Study ID Numbers ^ICMJE

PEPCAD-CTO V 2.3

Has Data Monitoring Committee

Responsible Party

Jochen Wöhrle, MD, FESC, University of Ulm, Ulm, Germany

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

B. Braun Melsungen AG

Investigators ^ICMJE

Principal Investigator:

Jochen Wöhrle, MD; FESC

University of Ulm, Ulm, Germany

Information Provided By

University of Ulm

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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