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NCT02715830 Clinical Trial

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

Atherosclerosis of Artery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02715830
Other study ID # UNIFESP01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2016
Est. completion date July 2017

Study information
Verified date August 2019
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Santa Marcelina Hospital Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time of wound healing Time in days necessary to the complete healing of the wound 1 year
Primary Limb Salvage Time free of major amputation 1 year
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