The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
NCT ID: NCT00670436
Last Updated: 2014-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2008-02-29
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A 1
paclitaxel eluting PTCA balloon (SeQuent please) after bare-metal stenting of a chronic total occlusion in a native coronary artery
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
A2
historical population of patients with a chronic total occlusion in a native coronary artery treated with the paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
Interventions
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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
paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
University of Ulm
OTHER
Responsible Party
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Jochen Wohrle
Prof. Dr. Jochen Wöhrle
Principal Investigators
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Jochen Wöhrle, MD; FESC
Role: PRINCIPAL_INVESTIGATOR
University of Ulm, Ulm, Germany
Locations
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Klinikum Darmstadt
Darmstadt, , Germany
University of Ulm
Ulm, , Germany
Countries
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References
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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.
Other Identifiers
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PEPCAD-CTO V 2.3
Identifier Type: -
Identifier Source: org_study_id
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