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NCT01938872 Clinical Trial

Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01938872
Other study ID # Arezzo010
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2013
Last updated September 5, 2013
Start date September 2013

Study information
Verified date September 2013
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

- lack of consent

- need for amputation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• paclitaxel eluting balloon angioplasty in below-the-knee lesions

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary angiographic binary restenosis incidence of binary restenosis 12 months No
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