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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715830
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Bruno Biagioni, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Atherosclerosis of Artery Procedure: Angioplasty of distal arteries Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: One Artery
In this arm after obtain the good result after the angioplasty of one artery the procedure stops
Procedure: Angioplasty of distal arteries
angioplasty of the arteries bellow-the-knee

Experimental: 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
Procedure: Angioplasty of distal arteries
angioplasty of the arteries bellow-the-knee




Primary Outcome Measures :
  1. Time of wound healing [ Time Frame: 1 year ]
    Time in days necessary to the complete healing of the wound

  2. Limb Salvage [ Time Frame: 1 year ]
    Time free of major amputation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715830


Locations
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Brazil
Santa Marcelina Hospital
Sao Paulo, Brazil, 08270000
Sponsors and Collaborators
Federal University of São Paulo
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Responsible Party: Rodrigo Bruno Biagioni, Dr, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02715830    
Other Study ID Numbers: UNIFESP01
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rodrigo Bruno Biagioni, Federal University of São Paulo:
angioplasty
infrapopliteal arteries
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases