NCT02279784

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

October 28, 2014

Last Update Submit

October 31, 2014

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • number of events of angiographic binary restenosis

    number of events of angiographic binary restenosis

    12 months

Secondary Outcomes (3)

  • number of events of target lesion revascularization

    12 months

  • number of events of death

    12 months

  • frequency of major amputation

    12 months

Study Arms (2)

Freeway

EXPERIMENTAL

angioplasty with Freeway drug-eluting balloon

Device: Freeway PTA

Lutonix

EXPERIMENTAL

angioplasty with Lutonix drug-eluting balloon

Device: Lutonix PTA

Interventions

Freeway PTADEVICE

angioplasty with Freeway drug-eluting balloon

Freeway
Lutonix PTADEVICE

angioplasty with Lutonix drug-eluting balloon

Lutonix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\>18 years
  • angiographic stenosis\>50% or occlusion of one below-knee vessel

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

October 1, 2016

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

IT(1)