Dutch Critical Limb Ischemia Registry

Rationale: The prevalence of peripheral arterial disease (PAD) is still rising. The end stage of PAD is critical limb ischemia (CLI) and is associated with high amputation- and mortality rates and low quality of life. CLI typically presents as crural or pedal arterial pathology. Despite international guidelines, there is still clinical variation in the treatment of CLI.
Objective: To investigate the best endovascular treatment modality in patients with CLI based on arterial pathology below the knee
Study design: A prospective multi-center cohort study.
Study population: Patients (≥ 18 years) with CLI based on arterial pathology below the knee.
Main study endpoints: The primary endpoints are limb salvage and primary patency. Limb salvage is defined as freedom from major amputations, i.e. amputations above the ankle. Primary patency is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and a significant restenosis on imaging.
Nature and extent of burden: No additional actions are required and no additional risks are taken by included patients. This study will not influence patient care.

New endovascular techniques, such as stents or drug-coated devices, demonstrate superior (patency and limb salvage) outcomes compared to conventional plain old balloon angioplasty (POBA) for critical limb ischemia (CLI) patients based on arterial pathology below the knee.

6 weeks, 6 months, 12 months, 24 months

An endovascular intervention on the below the knee arteries can imply plain old balloon angioplasty (POBA) with or without additional treatment modalities, such as vessel preparation devices, stenting or drug-coated devices.