Trial Comparing Different Medical Devices for Infragenual Dilatation

NCT ID: NCT00134277

Last Updated: 2011-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-04-30

Brief Summary

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This study is a comparison of different medical devices for infragenual dilatation.

Detailed Description

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Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).

Conditions

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Diabetic Angiopathies Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infragenual dilatation with stenting

Group Type ACTIVE_COMPARATOR

Infragenual dilatation with stenting

Intervention Type PROCEDURE

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Group Type ACTIVE_COMPARATOR

Infragenual dilatation with cutting balloon

Intervention Type PROCEDURE

Infragenual dilatation with cutting balloon

Laser therapy

Group Type ACTIVE_COMPARATOR

Laser therapy

Intervention Type PROCEDURE

Laser therapy

Infragenual dilatation

Group Type PLACEBO_COMPARATOR

Infragenual dilatation

Intervention Type PROCEDURE

Infragenual dilatation

Interventions

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Infragenual dilatation

Infragenual dilatation

Intervention Type PROCEDURE

Infragenual dilatation with stenting

Infragenual dilatation with stenting

Intervention Type PROCEDURE

Infragenual dilatation with cutting balloon

Infragenual dilatation with cutting balloon

Intervention Type PROCEDURE

Laser therapy

Laser therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
* Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)

Exclusion Criteria

* Acute ischemia
* Multisegmentaric damage above the knee
* Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) \> 30, white blood cell (WBC) \> 25,000
* Acute myocardial infarction (AMI) during the last 14 days
* Operative contraindication
* Life expectancy \< 2 years
* Blue toe syndrome (micro-embolisation)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caren Randon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2004/161

Identifier Type: -

Identifier Source: org_study_id

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