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

June 7, 2014 updated by: Jochen Wohrle, University of Ulm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt
      • Ulm, Germany, 89081
        • University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A 1
paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery
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
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)
Device: paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
percent diameter stenosis
Time Frame: 6 months
6 months
binary angiographic restenosis rate
Time Frame: 6 months
6 months
late loss index
Time Frame: 6 months
6 months
Target lumen revascularization
Time Frame: 30 days, 6, 12, 24 months
30 days, 6, 12, 24 months
target vessel revascularization
Time Frame: 30 days, 6, 12, 24 months
30 days, 6, 12, 24 months
major adverse cardiac events
Time Frame: 30 days, 6, 12, 24 months
30 days, 6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Jochen Wöhrle, MD; FESC, University of Ulm, Ulm, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEPCAD-CTO V 2.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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