Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.

It is a randomized study that intend to enroll 80 bellow-the-knee angioplasty procedures in which 40 procedures to treat one artery (standart) or more than one artery in the same procedure.

The aim of this study is to know if this strategy increase healing velocity and limb salvage.

Completed

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Key information

Conditions

Atherosclerosis of Artery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Santa Marcelina Hospital

São Paulo, 08270000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Occlusion of the three arteries bellow the knee previously
Rutherford 5 - ischemic lesion of the foot
Informative Term
At least one patente vessel in pedal arch

Exclusion criteria

allergy to aspirin, clopidogrel or contrast media
renal impairment
Tasc D lesion in femoral or popliteal arteries
no undersatnting patients

Treatment and study plan

Angioplasty of distal arteries

Procedure

angioplasty of the arteries bellow-the-knee

Primary outcomes

Time of wound healing

Time frame: 1 year

Time in days necessary to the complete healing of the wound
Limb Salvage

Time frame: 1 year

Time free of major amputation

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 22, 2016
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed