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Clinical Trial: Randomised Comparing Trial Between Different Medical Devices for Infragenual Dilatation
This study is currently recruiting patients.
Verified by University Hospital Ghent August 2005
|
Purpose
Comparison of different medical devices for infragenual dilatation
| Condition | Intervention |
|---|---|
| Diabetic Angiopathy Intermittent Claudication | Procedure: Infragenual dilatation Procedure: Infragenual dilatation with stenting Procedure: Infragenual dilatation with cutting balloon Procedure: Laser therapy |
MedlinePlus related topics: Diabetes; Leg Injuries and Disorders; Peripheral Vascular Diseases; Vascular Diseases
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:
Primary Outcomes: Primary patency after 6 months
Secondary Outcomes: Proving the superiority or non-superiority of one treatment procedure to another treatment procedure.
Expected Total Enrollment: 80
Secondary Outcomes: Proving the superiority or non-superiority of one treatment procedure to another treatment procedure.
Expected Total Enrollment: 80
Study start: September 2004
Last follow-up: August 2005
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
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: ARDS, CRP>30, WBC>25000
- AMI during the last 14 days
- Operative contra-indication
- Life expectancy < 2 years
- Blue toe syndrome (micro-embolisation)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00134277
Caren Randon, MD 0032/9/240.62.52 caren.randon@UGent.be
Belgium
University Hospital Ghent, Ghent, 9000, Belgium; Recruiting
Caren Randon, MD 0032/9/240.62.52 caren.randon@UGent.be
Study chairs or principal investigators
Caren Randon, MD, Principal Investigator, University Hospital Ghent
More Information
Website University Hospital Ghent
Study ID Numbers: 2004/161
Last Updated: August 26, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134277
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 26, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134277
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30
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