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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Artery

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