Status:
TERMINATED
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Aachen Resonance GmbH
Conditions:
Stable Angina
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo l...
Eligibility Criteria
Inclusion
- Patient ≥ 18years old
- Stable angina symptoms
- Elective treatment to coronary lesion
- Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection
Exclusion
- Left main stem lesion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01899235
Start Date
May 1 2011
End Date
March 1 2014
Last Update
March 18 2014
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000