Claudication, Intermittent, Critical Limb-Threatening Ischemia, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Peripheral Arterial Occlusive Disease
Conditions
Keywords
Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft
Brief summary
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.
Detailed description
Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies. This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.
Interventions
PROCEDUREFRAMED Infrainguinal Venous Bypass
The harvested vein graft will be covered with a mesh.
PROCEDUREConventional Autologous Bypass
The harvested vein graft will be used without a mesh coating.
Sponsors
Paracelsus Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnant or breastfeeding women * Active infection or sepsis * Acute ischemia * Endovascular procedure in the region to be treated. * Vein with outer diameter \<3.5 mm or \>8 mm under pressure. * Spliced Veins. * Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum). * Vasculitis * Coagulopathy * Radiation therapy near the anastomosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of primary patency of the venous bypass | 2 years | The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure-related mortality | 2 years | Mortality intervention-related |
| Incidence of 30-day mortality | 30 days | Number of participants, who die within 30 days after the procedure. |
| Incidence of limb salvage after procedure | 2 years | Amputation free survival |
Countries
Austria
Contacts
Primary ContactStephanie Rassam, MD
Backup ContactStephan Koter, MD, PD
Outcome results
None listed