Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

Peripheral Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02279784
• Other study ID #: Arezzo013
• Status: Recruiting
• Phase: Phase 4
• First received: October 28, 2014
• Last updated: October 31, 2014
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2014
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Description:

Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: December 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Freeway PTA
angioplasty with Freeway drug-eluting balloon
• Lutonix PTA
angioplasty with Lutonix drug-eluting balloon

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	number of events of angiographic binary restenosis	number of events of angiographic binary restenosis	12 months	No
Secondary	number of events of target lesion revascularization	number of events of target lesion revascularization	12 months	No
Secondary	number of events of death	number of events of death	12 months	No
Secondary	frequency of major amputation	frequency of major amputation	12 months	No