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SuperB Trial: SUrgical Versus PERcutaneous Bypass

NCT01220245 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2021-01-25

No results posted yet for this study

Summary

In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a \>50% stenosis or occlusion of the SFA over \>/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.

Conditions

Interventions

PROCEDURE

Heparin-bonded ePTFE endoluminal fem-pop bypass

Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass

PROCEDURE

Surgical femoro-popliteal bypass.

Surgical femoro-popliteal bypass.

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • MMJP Reijnen, MD, PhD · Rijnstate Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01220245 on ClinicalTrials.gov