Trial Comparing Different Medical Devices for Infragenual Dilatation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00134277
First received: August 23, 2005
Last updated: September 8, 2011
Last verified: September 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: After 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proving the superiority or non-superiority of one treatment procedure to another treatment procedure [ Time Frame: After 6 months. ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2004
Study Completion Date: April 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infragenual dilatation with stenting Procedure: Infragenual dilatation with stenting
Infragenual dilatation with stenting
Active Comparator: Infragenual dilatation with cutting balloon Procedure: Infragenual dilatation with cutting balloon
Infragenual dilatation with cutting balloon
Active Comparator: Laser therapy Procedure: Laser therapy
Laser therapy
Placebo Comparator: Infragenual dilatation Procedure: Infragenual dilatation
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).

  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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00134277     History of Changes
Other Study ID Numbers: 2004/161
Study First Received: August 23, 2005
Last Updated: September 8, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Angiopathies
Dilatation, Pathologic
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014