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

被引:10
作者
Schreve, Michiel A. [1 ]
Lichtenberg, Michael [2 ,3 ]
Unlu, Cagdas [1 ]
Branzan, Daniela [4 ,5 ]
Schmidt, Andrej [6 ]
van den Heuvel, Daniel A. F. [7 ,8 ]
Blessing, Erwin [9 ,10 ]
Brodmann, Marianne [11 ,12 ]
Cabane, Vincent [13 ]
Lin, William Tan Qing [14 ,15 ]
Kum, Steven [14 ,15 ]
机构
[1] Northwest Clin, Dept Vasc Surg, Wilhelminalaan 12, NL-1815 JD Alkmaar, Netherlands
[2] Arnsberg Clin, Vasc Ctr Arnsberg, Arnsberg, Germany
[3] Standort Karolinen Hosp, Stolte Ley 5, D-59759 Arnsberg, Germany
[4] Univ Hosp Leipzig, Dept Vasc Surg, Leipzig, Germany
[5] Univ Klinikum Leipzig AoR, Liebigstr 20, D-04103 Leipzig, Germany
[6] Univ Hosp Leipzig, Dept Angiol, Leipzig, Germany
[7] St Antonius Hosp, Dept Radiol, Nieuwegein, Netherlands
[8] Ziekenhuis Nieuwegein, Koekoekslaan 1, NL-3435 CM Nieuwegein, Netherlands
[9] SRH Klinikum Karlsbad Langensteinbach, Dept Intervent Angiol, Karlsbad, Germany
[10] SRH Klinikum Karlsbad Langensteinbach GmbH, Guttmannstr 1, D-76307 Karlsbad, Germany
[11] Med Univ Graz, Angiol, Graz, Austria
[12] Medi Univ Graz, Auenbruggerpl 27, A-8036 Graz, Austria
[13] LimFlow SA, 95 Blvd Pereire, F-75017 Paris, France
[14] Changi Gen Hosp, Vasc Serv, Dept Surg, Changi, Singapore
[15] Changi Gen Hosp Pte Ltd, 2 Simei St 3, Singapore 529889, Singapore
关键词
SALVAGE; SYSTEM;
D O I
10.1186/s42155-019-0067-z
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BackgroundCritical 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/designThe 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.DiscussionThe 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 registrationNCT03321552.
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页数:9
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