Choice of Material for Above-Knee Femoro-Popliteal Bypass... | NCT00300690

Studies
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)

NCT00300690

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Mar 9, 2006Estimated

Enrollment

400

Phase

Phase 4

Conditions

Intermittent Claudication
Critical Limb Ischemia

Interventions

6 mm Uni-graft® (B-Braun)
6 mm Gore-Tex® (WL Gore)

Countries

Not provided

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

Mar 2006

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

Oct 1993

Primary Completion Date

Not provided

Completion Date

Jan 1999

First Submitted Date

Mar 8, 2006

First Submission Date that Met QC Criteria

Mar 8, 2006

First Posted Date

Mar 9, 2006Estimated

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

Mar 8, 2006

Last Update Posted Date

Mar 9, 2006Estimated

Name	Class
B. Braun Melsungen AG	INDUSTRY

Description Module

Brief Summary

This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Detailed Description

Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary uncorrected graft patency after 2 years

Secondary Outcomes

Measure	Description	Time Frame
- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

Exclusion Criteria:

pregnancy
No consent to participate in the study
Previous enrollment in the study
follow-up is not possible

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
Torben V Schroeder, Professor	Rigshospitalet, Denmark	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007383	Intermittent Claudication
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
6 mm Uni-graft® (B-Braun)	Device
6 mm Gore-Tex® (WL Gore)	Device