To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions: 1. Cohort A: Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility 2. Cohort B: Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence).
Study Type
OBSERVATIONAL
Enrollment
40
UZ Leuven
Leuven, Belgium
University Hospital No4
Lubin, Poland
Ospedale Regionale di Lugano
Lugano, Switzerland
Safety
Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plaque distal to the device) at 30 days.
Time frame: Acute & 30 days
Pain
Reduction of pain.
Time frame: Acute & 30 days
Recurrent varices
Recurrence of varices requiring repeat embolizations within 30 days.
Time frame: 30 days
Occlusion
Sustained occlusion at 30 days follow-up.
Time frame: 30 days
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