Trial Comparing Different Medical Devices for Infragenual Dilatation

This study is ongoing, but not recruiting participants.

First Received: August 23, 2005 Last Updated: February 17, 2009 History of Changes

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00134277

Purpose

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

Condition	Intervention
Diabetic Angiopathies Intermittent Claudication	Procedure: Infragenual dilatation Procedure: Infragenual dilatation with stenting Procedure: Infragenual dilatation with cutting balloon Procedure: Laser therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy

Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment:	80
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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 letsels (30 - 120 minutes).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134277

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Caren Randon, MD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Caren Randon )
Study ID Numbers:	2004/161
Study First Received:	August 23, 2005
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00134277 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Signs and Symptoms
Dilatation, Pathologic
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Intermittent Claudication
Endocrinopathy
Arteriosclerosis
Diabetes Complications
Diabetic Angiopathies

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Signs and Symptoms
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Intermittent Claudication
Cardiovascular Diseases
Arteriosclerosis
Diabetes Complications
Diabetic Angiopathies

ClinicalTrials.gov processed this record on May 07, 2009