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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis of Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, there is no use of other drugs, biological vaccine or combination product, but it was used two different approaches to the same problem: the renalization of the tibial arteries in patients with tissue loss. The angioplasty, that is the usual method of treatment, is done for one or more than one artery after randomization. It is phase 4 because it is an usual method of treatment (gold standard) for this disease.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The moment of randomization was after the successful accomplish of the recanalizaripn of the first artery. The used 80 sealed papers - 40 for each treatment. The nurse pick up one of the mixed papers and the procedure stops or continuous to the another artery depending on the randomization.

Study Groups

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One Artery

In this arm after obtain the good result after the angioplasty of one artery the procedure stops

Group Type EXPERIMENTAL

Angioplasty of distal arteries

Intervention Type PROCEDURE

angioplasty of the arteries bellow-the-knee

More than one artery

In this arm, after obtain a good result of the angioplasty of one artery, we continue trying one or two more arteries

Group Type EXPERIMENTAL

Angioplasty of distal arteries

Intervention Type PROCEDURE

angioplasty of the arteries bellow-the-knee

Interventions

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Angioplasty of distal arteries

angioplasty of the arteries bellow-the-knee

Intervention Type PROCEDURE

Eligibility Criteria

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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