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

Primary Purpose

Atherosclerosis of Artery

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Angioplasty of distal arteries

About this trial

This is an interventional treatment trial for Atherosclerosis of Artery focused on measuring angioplasty, infrapopliteal arteries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Santa Marcelina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

One Artery

More than one artery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time of wound healing

Time in days necessary to the complete healing of the wound

Limb Salvage

Time free of major amputation

Secondary Outcome Measures

Full Information

NCT ID

NCT02715830

First Posted

March 17, 2016

Last Updated

August 22, 2019

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02715830

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis of Artery

Keywords

angioplasty, infrapopliteal arteries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One Artery

Arm Type

Experimental

Arm Description

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

Arm Title

More than one artery

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Angioplasty of distal arteries

Intervention Description

angioplasty of the arteries bellow-the-knee

Primary Outcome Measure Information:

Title

Time of wound healing

Description

Time in days necessary to the complete healing of the wound

Time Frame

1 year

Title

Limb Salvage

Description

Time free of major amputation

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Santa Marcelina Hospital

City

Sao Paulo

ZIP/Postal Code

08270000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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