Trial Comparing Different Medical Devices for Infragenual Dilatation

Intermittent Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134277
• Other study ID #: 2004/161
• Status: Completed
• Phase: N/A
• First received: August 23, 2005
• Last updated: September 8, 2011
• Start date: September 2004
• Est. completion date: April 2010

Study information

• Verified date: September 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Intermittent Claudication

Intervention

Procedure:
• Infragenual dilatation
Infragenual dilatation
• Infragenual dilatation with stenting
Infragenual dilatation with stenting
• Infragenual dilatation with cutting balloon
Infragenual dilatation with cutting balloon
• Laser therapy
Laser therapy

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency after 6 months		After 6 months	No
Secondary	Proving the superiority or non-superiority of one treatment procedure to another treatment procedure		After 6 months.	No

External Links

•   Website University Hospital Ghent