Venclose digiRF System Post Market Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GSV/SSV Incompetent Great and Small Saphenous Veins |
Device: Venclose digiRF System
The Venclose digiRF System is intended for use in endovascular coagulation of blood vessels in patients with superficial, perforator, and tributary vein reflux.
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| Experimental: IPV Incompetent Perforator Veins |
Device: Venclose digiRF System
The Venclose digiRF System is intended for use in endovascular coagulation of blood vessels in patients with superficial, perforator, and tributary vein reflux.
|
Outcome Measures
Primary Outcome Measures
- Occlusion [1-Month]
Cumulative Incidence of Occlusion
- DVT & PE Serious Adverse Events [1-Month]
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events
Secondary Outcome Measures
- revised Venous Clinical Severity Score (rVCSS) [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]
Distribution of rVCSS score
- ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20) [Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits]
Distribution of CIVIQ-20 score
- Clinical Etiological Anatomical Pathophysiological (CEAP) [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]
Distribution of CEAP clinical class
- Visual Analog Scale for Pain (VAS) [Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits]
Distribution of VAS Pain score
- Recanalization [1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits]
Proportion of Recanalization of treated veins
- Duration of Procedure [Day 1 Index Procedure visit]
Mean Duration of Procedure
- Endovenous Heat Induced Thrombosis (2-4) [1-Month (+7 days) visit]
Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is age 18 and older
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Subject has CEAP clinical class C2 and higher.
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Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
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GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
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For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
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For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
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For IPV only: IPVs must be located under a healed or active ulcer.
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Is able to ambulate.
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Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
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Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion Criteria:
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Has had previous treatment for venous insufficiency in the same target vein.
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Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
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Has thrombus in the vein segment to be treated.
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Has untreated critical limb ischemia from peripheral arterial disease.
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Is undergoing active anticoagulant therapy for acute Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
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Subjects with known bleeding and/or clotting disorders.
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Has ABI <0.8
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Subject is pregnant or breastfeeding
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For GSV/SSV only: has a BMI >35.
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For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
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Unable to ambulate, or restrictive ambulation.
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Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
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Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
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Has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- C. R. Bard
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BDPI-21-006