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Clinical Trials/NCT00670436
NCT00670436
Completed
Phase 2

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

University of Ulm2 sites in 1 country48 target enrollmentFebruary 2008
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ConditionsCoronary Artery DiseaseChronic Total OcclusionNative Coronary Artery

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Ulm
Enrollment
48
Locations
2
Primary Endpoint
Late loss
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
March 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Ulm
Responsible Party
Principal Investigator
Principal Investigator

Jochen Wohrle

Prof. Dr. Jochen Wöhrle

University of Ulm

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

Outcomes

Primary Outcomes

Late loss

Time Frame: 6 months

Secondary Outcomes

  • percent diameter stenosis(6 months)
  • late loss index(6 months)
  • target vessel revascularization(30 days, 6, 12, 24 months)
  • major adverse cardiac events(30 days, 6, 12, 24 months)
  • binary angiographic restenosis rate(6 months)
  • Target lumen revascularization(30 days, 6, 12, 24 months)

Study Sites (2)

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