The Dutch LimFlow registry; a clinical post marketing trial investigating the long term results after a Percutaneous Deep Vein Arterialization (LimFlow) in the treatment of no-option chronic limb threatening ischemia patient.

Chronic limb threatening ischemia (CLTI) is the clinical end stage of peripheral artery disease (PAD) and is associated with high amputation, mortality rates and poor quality of life. For CLTI patients with no revascularization options, venous arterialization could be an alternative technique for limb salvage. A recent development, is the Percutaneous Deep Vein Arterialization (pDVA) which is a novel, minimally invasive, endovascular approach to perform a venous arterialization procedure. Major advantage of this approach is the minimal invasiveness with lower periprocedural risks and no creation of wounds in an already critically ischemic leg. Our hypothesis is that in patients with no-option CLTI, a treatment with pDVA is a feasible, safe, and a clinically effective approach. Therefore, we initiated a prospective clinical cohort trial to investigate the outcome of the pDVA in no-option CLTI patients in the Netherlands.
The study population consists of patients with a clinical diagnosis of symptomatic CLTI, defined as Rutherford category 4, 5 or 6 with the assessment that no conventional surgical or endovascular treatment is possible. The patients will undergo a percutaneous deep vein arterialization (pDVA).
Our primary outcome is amputation free survival. Secondary endpoints are complete wound healing, primary and secondary patency, limb salvage, renal function, quality of Life, cardial effect and cost effectiveness.

Our hypothesis is that in patients with no-option critical limb ischemia, a treatment with pDVA is a feasible, safe and a clinically effective approach.

12 months and 24 months follow-up

Percutaneous deep venous arterialization