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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Varicocele arising from the spermatic vein(s) and pampiniform plexus, with or without concomitant diagnosis of infertility or subfertility | ||
| Cohort B | Pelvic varices in females for the treatment of pelvic congestion syndrome (e.g., pelvic venous incompetence). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Acute & 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Reduction of pain. | Acute & 30 days |
| Recurrent varices | Recurrence of varices requiring repeat embolizations within 30 days. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects requiring permanent occlusion of the peripheral vessels for the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Geert Maleux, MD | UZ Leuven, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Belgium | ||||
| University Hospital No4 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23703667 | Background | Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24. |
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| ID | Term |
|---|---|
| D014646 | Varicocele |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Occlusion | Sustained occlusion at 30 days follow-up. | 30 days |
| Lubin |
| Poland |
| Ospedale Regionale di Lugano | Lugano | Switzerland |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |