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

Primary Purpose

Coronary Artery Disease, Chronic Total Occlusion, Native Coronary Artery

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
paclitaxel eluting PTCA balloon catheter (SeQuent Please)
paclitaxel eluting Taxus stent (Boston Scientific)
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Darmstadt
  • University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A 1

A2

Arm Description

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

historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)

Outcomes

Primary Outcome Measures

Late loss

Secondary Outcome Measures

percent diameter stenosis
binary angiographic restenosis rate
late loss index
Target lumen revascularization
target vessel revascularization
major adverse cardiac events

Full Information

First Posted
April 29, 2008
Last Updated
June 7, 2014
Sponsor
University of Ulm
Collaborators
B. Braun Melsungen AG
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1. Study Identification

Unique Protocol Identification Number
NCT00670436
Brief Title
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Acronym
PEPCAD-CTO
Official Title
The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Chronic Total Occlusion, Native Coronary Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A 1
Arm Type
Active Comparator
Arm Description
paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery
Arm Title
A2
Arm Type
Active Comparator
Arm Description
historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)
Intervention Type
Device
Intervention Name(s)
paclitaxel eluting PTCA balloon catheter (SeQuent Please)
Other Intervention Name(s)
SeQuent Please, paclitaxel eluting balloon
Intervention Description
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
Intervention Type
Device
Intervention Name(s)
paclitaxel eluting Taxus stent (Boston Scientific)
Intervention Description
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
Primary Outcome Measure Information:
Title
Late loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
percent diameter stenosis
Time Frame
6 months
Title
binary angiographic restenosis rate
Time Frame
6 months
Title
late loss index
Time Frame
6 months
Title
Target lumen revascularization
Time Frame
30 days, 6, 12, 24 months
Title
target vessel revascularization
Time Frame
30 days, 6, 12, 24 months
Title
major adverse cardiac events
Time Frame
30 days, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Wöhrle, MD; FESC
Organizational Affiliation
University of Ulm, Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Darmstadt
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22511572
Citation
Wohrle 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.
Results Reference
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The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

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