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

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Atherosclerosis of Artery

Treatments: Procedure: Angioplasty of distal arteries

Study type: Interventional

Funder types: Other

Identifiers

NCT02715830

UNIFESP01

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

One Artery

Experimental group

Description:

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

Treatment:

Procedure: Angioplasty of distal arteries

More than one artery

Experimental group

Description:

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

Treatment:

Procedure: Angioplasty of distal arteries