FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

ConditionsPeripheral Arterial Occlusive Disease Femoropopliteal Artery Occlusion Femoropopliteal Stenosis Critical Limb-Threatening Ischemia Claudication, Intermittent

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorParacelsus Medical University

About this trial

The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.

Eligibility criteria

Qualifiers

Age at least 18 years

Informed consent form with signature

Rutherford Category 3 (<200m) or chronic critical ischemia (Rutherford Category 4-6)

Assured inflow and recipient artery.

Disqualifiers

Pregnant or breastfeeding women

Active infection or sepsis

Acute ischemia

Endovascular procedure in the region to be treated.

Trial design

Treatments tested in this trial

FRAMED Infrainguinal Venous Bypass
Conventional Autologous Bypass

Treatment groups

110 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Paracelsus Medical University

Lead sponsor

Source ClinicalTrials.gov