Randomized Clinical Trial in Bellow-the-knee Angioplasty.... | NCT02715830

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

NCT02715830

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Atherosclerosis of Artery

Interventions

Angioplasty of distal arteries

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 17, 2016

First Posted Date

Mar 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One Artery	Experimental	In this arm after obtain the good result after the angioplasty of one artery the procedure stops	Procedure: Angioplasty of distal arteries
More than one artery	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Angioplasty of distal arteries	Procedure	angioplasty of the arteries bellow-the-knee	More than one artery One Artery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Marcelina Hospital		São Paulo		08270000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 20, 2020
Reset	Aug 10, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 20, 2020			Aug 10, 2020

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.

Masking Info

Masking

Single

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.

Who Masked

Participant