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

NCT02715830 | Completed Phase 4

• 1 other identifier: UNIFESP01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis of Artery

Keywords

angioplasty; infrapopliteal arteries

Outcome Measures

Primary Outcomes (2)

• Time of wound healing

  Time in days necessary to the complete healing of the wound

  1 year

• Limb Salvage

  Time free of major amputation

  1 year

Study Arms (2)

One Artery

EXPERIMENTAL

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

Procedure: Angioplasty of distal arteries

More than one artery

EXPERIMENTAL

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

Procedure: Angioplasty of distal arteries

Interventions

Angioplasty of distal arteries PROCEDURE

angioplasty of the arteries bellow-the-knee

More than one artery; One Artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Santa Marcelina Hospital

São Paulo, 08270000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)