PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient.

Autor: Schreve MA; Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands, Wilhelminalaan 12, 1815 JD, Alkmaar, the Netherlands. mschreve@rkz.nl., Lichtenberg M; Vascular Centre Arnsberg, Arnsberg Clinic, Arnsberg, Germany.; Standort Karolinen-Hospital, Stolte Ley 5, 59759, Arnsberg, Germany., Ünlü Ç; Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands, Wilhelminalaan 12, 1815 JD, Alkmaar, the Netherlands., Branzan D; Department of Vascular Surgery, University Hospital Leipzig, Leipzig, Germany.; Universitätsklinikum Leipzig AöR, Liebigstraße 20, 04103, Leipzig, Germany., Schmidt A; Department of Angiology, University Hospital Leipzig, Leipzig, Germany., van den Heuvel DAF; Department of Radiology, St. Antonius Hospital, Nieuwegein, the Netherlands.; Ziekenhuis Nieuwegein, Koekoekslaan 1, 3435, CM, Nieuwegein, the Netherlands., Blessing E; Department of Interventional Angiology, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.; SRH Klinikum Karlsbad-Langensteinbach GmbH, Guttmannstraße 1, 76307, Karlsbad, Germany., Brodmann M; Angiologie, Medizinische Universtität Graz, Graz, Austria.; Medizinische Universtität Graz, Auenbruggerplatz 27, 8036, Graz, Austria., Cabane V; LimFlow SA,Paris, France, 95 Boulevard Pereire, 75017, Paris, France., Lin WTQ; Department of Surgery, Vascular Service, Changi General Hospital, Changi, Singapore.; Changi General Hospital Pte Ltd, 2 Simei Street 3, Singapore, 529889, Singapore., Kum S; Department of Surgery, Vascular Service, Changi General Hospital, Changi, Singapore.; Changi General Hospital Pte Ltd, 2 Simei Street 3, Singapore, 529889, Singapore.
Jazyk: angličtina
Zdroj: CVIR endovascular [CVIR Endovasc] 2019 Jul 31; Vol. 2 (1), pp. 26. Date of Electronic Publication: 2019 Jul 31.
DOI: 10.1186/s42155-019-0067-z
Abstrakt: Background: Critical limb ischemia (CLI) is the clinical end stage of peripheral artery disease and is associated with high amputation, mortality rates and poor quality of life. For CLI patients with no revascularization options, venous arterialization could be an alternative technique for limb salvage. A systematic review and meta-analysis published in 2017 concluded that venous arterialization may be considered a viable alternative. A recent development, is the Percutaneous Deep Vein Arterialization (pDVA), that is CE-marked and currently under investigation of the FDA. This procedure, called LimFlow, is a novel, minimally invasive, endovascular approach to perform a venous arterialization procedure. The limited evidence for its use necessitates a scientific judgement of the pDVA. Therefore, we initiated a prospective clinical post market trial to investigate the outcome of the pDVA in no-option critical limb ischemia.
Methods/design: The objective of this prospective study is to collect "real-life" clinical data among a population of patients treated with the pDVA in order to evaluate the clinical effectiveness and safety of the LimFlow System in patients with no-option critical limb ischemia. This study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on up to fifty (50) eligible patients with a twelve-month follow-up period. The Primary endpoint is measured by amputation free survival. Secondary endpoints are complete wound healing, primary and secondary patency, limb salvage, renal function and technical and procedural success. Patients will be assessed at regular intervals during one year after the initial percutaneous deep vein arterialization procedure through clinical evaluation and self-completed questionnaires.
Discussion: The last decade several studies have been published with promising results and the number of treated patients has considerably grown. Venous arterialization could be a valuable treatment option in patients with often no other options than amputation of the affected limb. The first results in men are promising although more research and long term follow up is needed to establish the efficacy of this new treatment modality. With this prospective study, we evaluate the clinical effectiveness and safety in patients with no-option CLI treated with the pDVA (LimFlow System).
Trial Registration: NCT03321552 .
Databáze: MEDLINE
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