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Completed

NCT Number: NCT00134277

Trial Comparing Different Medical Devices for Infragenual Dilatation

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

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Key information

Conditions

Diabetic Angiopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infragenual dilatation

Procedure

Infragenual dilatation

Infragenual dilatation with stenting

Procedure

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Procedure

Infragenual dilatation with cutting balloon

laser therapy

Procedure

Laser therapy

Primary outcomes

  1. Primary patency after 6 months

    Time frame: After 6 months

Secondary outcomes

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

    Time frame: After 6 months.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Aug 24, 2005
Registry last updated
Sep 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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