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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02715830

Enrollment

Registered

2016-03-22

Start date

2016-03-31

Completion date

2017-07-31

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis of Artery

Keywords

angioplasty, infrapopliteal arteries

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.

Interventions

PROCEDUREAngioplasty of distal arteries

angioplasty of the arteries bellow-the-knee

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026