Multicentric, Prospective, Randomized, Comparing Trial Be... | NCT00147979

Status Module

Record Verification Date

Dec 2014

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

Apr 2004

Primary Completion Date

Jan 2009Actual

Completion Date

Aug 2013Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 7, 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

Dec 4, 2014

Last Update Posted Date

Dec 5, 2014Estimated

Name	Class
JOTEC Company	OTHER

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

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Detailed Description

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.

Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

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

596Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PTFE with bounded heparin	Device: Bridging by PTFE with bounded heparin
2	Active Comparator	PTFE without bounded heparin	Device: Bridging by PTFE without bounded heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bridging by PTFE with bounded heparin	Device	Bridging by PTFE with bounded heparin	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary patency after 2 years		after 2 years

Secondary Outcomes

Measure	Description	Time Frame
Secondary patency		after 2 years
Limb salvage		after 2 years
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
Reasonable outflow arteria
Informed consent
Patient able to take part in all follow-up examinations

Exclusion Criteria:

Acute ischemia of the leg
Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
< 18 years
Pregnancy
Recent heart attack (< 1 month)
Life expectancy less than 12 months
Known allergy to heparin
Known contrast allergy
Known bleeding or coagulation disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Vermassen, MD, PhD	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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases