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A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSV/SSV | Experimental | Incompetent Great and Small Saphenous Veins |
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| IPV | Experimental | Incompetent Perforator Veins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venclose System (digiRF generator w EVSRF catheter) | Device | The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux. |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion | Cumulative Incidence of Occlusion | 1-Month |
| DVT & PE Serious Adverse Events | Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events | 1-Month |
| Measure | Description | Time Frame |
|---|---|---|
| revised Venous Clinical Severity Score (rVCSS) | Distribution of rVCSS score | Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits |
| ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinRe | Thornton | Colorado | 80602 | United States | ||
| Pacific Vascular Institute |
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| Venclose MAVEN System (digiRF generator w MAVEN catheter) | Device | The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux. |
|
Distribution of CIVIQ-20 score |
| Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits |
| Clinical Etiological Anatomical Pathophysiological (CEAP) | Distribution of CEAP clinical class | Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits |
| Visual Analog Scale for Pain (VAS) | Distribution of VAS Pain score | Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits |
| Recanalization | Proportion of Recanalization of treated veins | 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits |
| Duration of Procedure | Mean Duration of Procedure | Day 1 Index Procedure visit |
| Endovenous Heat Induced Thrombosis (2-4) | Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4 | 1-Month (+7 days) visit |
| Kailua |
| Hawaii |
| 96740 |
| United States |
| Eastlake Cardiovascular | Roseville | Michigan | 48066 | United States |
| Englewood Hospital | Englewood | New Jersey | 07631 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Christus Health | Tyler | Texas | 75702 | United States |
| ClinRe | Colonial Heights | Virginia | 23834 | United States |