Trial Comparing Different Medical Devices for Infragenual... | NCT00134277

Studies
Trial Comparing Different Medical Devices for Infragenual Dilatation

NCT00134277

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Sep 9, 2011Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Diabetic Angiopathies
Intermittent Claudication

Interventions

Infragenual dilatation
Infragenual dilatation with stenting
Infragenual dilatation with cutting balloon
Laser therapy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Jan 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Aug 23, 2005

First Submission Date that Met QC Criteria

Aug 23, 2005

First Posted Date

Aug 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2011

Last Update Posted Date

Sep 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a comparison of different medical devices for 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Infragenual dilatation with stenting	Active Comparator	Procedure: Infragenual dilatation with stenting
Infragenual dilatation with cutting balloon	Active Comparator	Procedure: Infragenual dilatation with cutting balloon
Laser therapy	Active Comparator	Procedure: Laser therapy
Infragenual dilatation	Placebo Comparator	Procedure: Infragenual dilatation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infragenual dilatation	Procedure	Infragenual dilatation	Infragenual dilatation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary patency after 6 months		After 6 months

Secondary Outcomes

Measure	Description	Time Frame
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure		After 6 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caren Randon, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D003925	Diabetic Angiopathies
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015607	Stents
D053685	Laser Therapy

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided