An interventional study of FRAMED Infrainguinal Venous Bypass and Conventional Autologous Bypass in Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion and Femoropopliteal Stenosis, sponsored by Paracelsus Medical University. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Paracelsus Medical University · Not applicable, Interventional, and Treatment
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.
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 110 is above the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Paracelsus Medical University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Conventional Autologous Bypass
Procedure: FRAMED Infrainguinal Venous Bypass
The harvested vein graft will be covered with a mesh.
The harvested vein graft will be used without a mesh coating.
Incidence of primary patency of the venous bypass
The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.
Time frame: 2 years
Incidence of procedure-related mortality
Mortality intervention-related
Time frame: 2 years
Incidence of 30-day mortality
Number of participants, who die within 30 days after the procedure.
Time frame: 30 days
Incidence of limb salvage after procedure
Amputation free survival
Time frame: 2 years
Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 24 months after the start.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 24 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
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Paracelsus Medical University