A prospective, single-arm, multicenter, open-label, First-in-Human \& Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs. The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.
Hospital Universitario Y Politécnico La Fe
Valencia, Spain
Peri-procedure serious adverse events related to amber SEL-P (Stage I)
Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.
Time frame: Up to 24 hours after embolization procedure
Rate of complete vascular occlusion (Stage II)
Rate of complete vascular occlusion as defined by angiography at the end of the procedure.
Time frame: Embolization procedure day
Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)
Rate of any peri-procedure adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.
Time frame: Up to 24 hours after embolization procedure
Rate of complete vascular occlusion according clinical indication (Stage II)
Rate of complete vascular occlusion as defined by angiography at the end of the procedure according to clinical indication. * Vascular anomalies (excluding the central nervous system and central circulatory system). * Hemorrhages, aneurysms, and pseudoaneurysms. * Varicose veins (including hemorrhoids, varicocele, and pelvic congestion syndrome). * Portal embolization. * Hypervascular tumors. * Type II endoleaks. * Pathological organs (renal grafts, hypersplenism).
Time frame: Embolization procedure day
Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)
Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.
Time frame: Up to 24 hours after embolization procedure
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