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CompletedNCT02715830Updated Aug 28, 2019

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

A Phase 4 interventional study of Angioplasty of distal arteries in Atherosclerosis of Artery, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atherosclerosis of Artery

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Keywords

  • angioplasty
  • infrapopliteal arteries
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In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 80 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • allergy to aspirin, clopidogrel or contrast media
  • renal impairment
  • Tasc D lesion in femoral or popliteal arteries
  • no undersatnting patients
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureAngioplasty of distal arteries

    angioplasty of the arteries bellow-the-knee

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What researchers measure

Primary outcomes

  1. Time of wound healing

    Time in days necessary to the complete healing of the wound

    Time frame: 1 year

  2. Limb Salvage

    Time free of major amputation

    Time frame: 1 year

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Study locations

1 site
  • Santa Marcelina Hospital
    Sao Paulo, 08270000, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02715830
Lead sponsor
Federal University of São Paulo
Responsible party
Rodrigo Bruno Biagioni (Dr, Federal University of São Paulo) — Principal investigator
First posted
Mar 22, 2016
Start date
Mar 2016
Primary completion
Jun 2017
Completion
Jul 2017
Last update
Aug 28, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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