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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

Primary Purpose

Peripheral Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

PEB

PES

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring femoropopliteal lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cardiovascular Department, Ospedale S.DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PEB

PES

Arm Description

PEB angioplasty plus provisional nitinol stent implantation

Systematic PES angioplasty

Outcomes

Primary Outcome Measures

angiographic binary restenosis

incidence of binary restenosis

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01969630

First Posted

October 21, 2013

Last Updated

October 21, 2013

Sponsor

Ospedale San Donato

1. Study Identification

Unique Protocol Identification Number

NCT01969630

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ospedale San Donato

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease

Keywords

femoropopliteal lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEB

Arm Type

Active Comparator

Arm Description

PEB angioplasty plus provisional nitinol stent implantation

Arm Title

PES

Arm Type

Experimental

Arm Description

Systematic PES angioplasty

Intervention Type

Device

Intervention Name(s)

PEB

Intervention Description

Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation

Intervention Type

Device

Intervention Name(s)

PES

Intervention Description

Systematic Paclitaxel eluting stent angioplasty

Primary Outcome Measure Information:

Title

angiographic binary restenosis

Description

incidence of binary restenosis

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Composite of all cause mortality, major amputation and target lesion revascularization.

Description

incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cardiovascular Department, Ospedale S.Donato

City

Arezzo

State/Province

ZIP/Postal Code

52100

Country

Italy

Individual Site Status

Recruiting

Facility Contact: