Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

Peripheral Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969630
• Other study ID #: Arezzo011
• Status: Recruiting
• Phase: Phase 4
• First received: October 21, 2013
• Last updated: October 21, 2013
• Start date: October 2013

Study information

• Verified date: October 2013
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intermittent claudication or critical limb ischemia

• de novo stenosis = 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries

• presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk

• presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)

Exclusion Criteria:

• life expectancy <1 year

• contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel

• need for major amputation (MA) at the time of enrolment

• Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• PEB
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
• PES
Systematic Paclitaxel eluting stent angioplasty

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
Secondary	Composite of all cause mortality, major amputation and target lesion revascularization.	incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.	12 months	No