The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
NCT ID: NCT01899235
Last Updated: 2014-03-18
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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TERMINATED
PHASE4
INTERVENTIONAL
2011-05-31
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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TREATMENT
Study Groups
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Stent
drug eluting stent (Resolute)
drug eluting stent
drug eluting balloon
drug eluting balloon (Elutax)
drug eluting balloon
Interventions
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drug eluting balloon
drug eluting stent
Eligibility Criteria
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Inclusion Criteria
* Stable angina symptoms
* Elective treatment to coronary lesion
* Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection
Exclusion Criteria
* Bifurcation lesions
* Acute coronary syndrome (UAP, NSTEMI, STEMI)
* Cardiogenic shock
* Chronic total occlusion
* Additional lesions requiring PCI
* Platelet count ≤ 50 x 109/mm3
* Left ventricular ejection fraction ≤ 30%
* Patient life expectancy less than 12 months
* Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
* Participation in another investigational drug or device study
* Patient unable to give informed consent
18 Years
ALL
No
Sponsors
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Aachen Resonance GmbH
INDUSTRY
Aalborg University Hospital
OTHER
Responsible Party
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Svend Eggert Jensen
Associate professor, MD, PhD
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Countries
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Other Identifiers
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N-20110015
Identifier Type: -
Identifier Source: org_study_id
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