Randomized Clinical Trial in Bellow-the-knee Angioplasty. Treatment of One or More Than One Artery.
August 22, 2019 updated by: Rodrigo Bruno Biagioni, Federal University of São Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sao Paulo, Brazil, 08270000
- Santa Marcelina Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: One Artery
In this arm after obtain the good result after the angioplasty of one artery the procedure stops
|
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
|
angioplasty of the arteries bellow-the-knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of wound healing
Time Frame: 1 year
|
Time in days necessary to the complete healing of the wound
|
1 year
|
|
Limb Salvage
Time Frame: 1 year
|
Time free of major amputation
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
March 17, 2016
First Submitted That Met QC Criteria
March 17, 2016
First Posted (Estimate)
March 22, 2016
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 22, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNIFESP01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.