Unknown statusInterventionalPhase 4Updated Oct 25, 2013
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia | NCT01938872 | Trialant
Unknown statusObservationalUpdated Sep 10, 2013
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
ClinicalTrials.gov ID
NCT01938872
Lead Sponsor
Ospedale San DonatoOTHER
Overall Status
Unknown status
Study Type
Observational
Enrollment
100Estimated
Last Update Posted
Sep 10, 2013Estimated
Start Date
Sep 2013
Primary Completion Date
Sep 2015Estimated
Brief Summary
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months
Critical Limb Ischemia
paclitaxel eluting balloon angioplasty in below-the-knee lesions
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>18 years
angiographic stenosis>50% or occlusion of one below-knee vessel
Exclusion Criteria:
allergy to Paclitaxel
contraindication for combined antiplatelet treatment
life expectancy <1 year
hypersensitivity or contraindication to one of the study drugs