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Trial Comparing Different Medical Devices for Infragenual Dilatation

Primary Purpose

Diabetic Angiopathies, Intermittent Claudication

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Infragenual dilatation

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Laser therapy

About this trial

This is an interventional treatment trial for Diabetic Angiopathies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Laser therapy

Infragenual dilatation

Arm Description

Outcomes

Primary Outcome Measures

Primary patency after 6 months

Secondary Outcome Measures

Proving the superiority or non-superiority of one treatment procedure to another treatment procedure

Full Information

NCT ID

NCT00134277

First Posted

August 23, 2005

Last Updated

September 8, 2011

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00134277

Brief Title

Trial Comparing Different Medical Devices for Infragenual Dilatation

Official Title

Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Angiopathies, Intermittent Claudication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Infragenual dilatation with stenting

Arm Type

Active Comparator

Arm Title

Infragenual dilatation with cutting balloon

Arm Type

Active Comparator

Arm Title

Laser therapy

Arm Type

Active Comparator

Arm Title

Infragenual dilatation

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

Infragenual dilatation

Intervention Description

Infragenual dilatation

Intervention Type

Procedure

Intervention Name(s)

Infragenual dilatation with stenting

Intervention Description

Infragenual dilatation with stenting

Intervention Type

Procedure

Intervention Name(s)

Infragenual dilatation with cutting balloon

Intervention Description

Infragenual dilatation with cutting balloon

Intervention Type

Procedure

Intervention Name(s)

Laser therapy

Intervention Description

Laser therapy

Primary Outcome Measure Information:

Title

Primary patency after 6 months

Time Frame

After 6 months

Secondary Outcome Measure Information:

Title

Proving the superiority or non-superiority of one treatment procedure to another treatment procedure

Time Frame

After 6 months.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caren Randon, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

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Trial Comparing Different Medical Devices for Infragenual Dilatation

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