NCT01938872

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

September 5, 2013

Last Update Submit

September 5, 2013

Conditions

Critical Limb Ischemia

Keywords

critical limb ischemiadrug-eluting balloonrestenosis

Outcome Measures

Primary Outcomes (1)

  • angiographic binary restenosis

    incidence of binary restenosis

    12 months

Study Arms (1)

PEB angioplasty

paclitaxel eluting balloon angioplasty in below-the-knee lesions

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

Interventions

paclitaxel eluting balloon angioplasty in below-the-knee lesionsPROCEDURE
Also known as: FREEWAY™ (Eurocor GmbH)
PEB angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia

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

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

IT(1)