clinical trial · NCT04003480
FRAME, External Support for Lower Limb Autologous Grafts
Vascular Graft Solutions Ltd.·N/A·suspended·n = 30
Peripheral Arterial DiseasePeripheral Artery DiseaseFRAME
brief summary
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment autologous saphenous vein. Subjects will be followed for 5 years, with follow up visits at 1, 3, 6, 12 months, 2, 3, 4, 5, years post operation.
started
Dec 31, 2026
primary completion
Dec 1, 2028
completion
Dec 1, 2029
last updated
Feb 4, 2025
official title
Prospective, Multicenter Study Evaluating the Performance and Safety of FRAME, External Support for Lower Limb Autologous Grafts.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol