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

Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300690

Enrollment

400

Registered

2006-03-09

Start date

1993-10-31

Completion date

1999-01-31

Last updated

2006-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Intermittent Claudication

Keywords

Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material

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

Interventions

DEVICE6 mm Uni-graft® (B-Braun)

DEVICE6 mm Gore-Tex® (WL Gore)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Primary uncorrected graft patency after 2 years	—

Secondary

Measure	Time frame
- Secondary graft patency after two years	—
- Limb survival after two years	—
- Complication rate perioperatively	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026