Chronic Venous Insufficiency, Venous Reflux
Conditions
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.
Interventions
DEVICEVenclose System (digiRF generator w EVSRF catheter)
The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
DEVICEVenclose MAVEN System (digiRF generator w MAVEN catheter)
The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.
Sponsors
C. R. Bard
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is age 18 and older 2. Subject has CEAP clinical class C2 and higher. 3. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated. 4. 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. 5. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm. 6. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm. 7. For IPV only: IPVs must be located under a healed or active ulcer. 8. Is able to ambulate. 9. Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study. 10. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion criteria
1. Has had previous treatment for venous insufficiency in the same target vein. 2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site. 3. Has thrombus in the vein segment to be treated. 4. Has untreated critical limb ischemia from peripheral arterial disease. 5. 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. 6. Subjects with known bleeding and/or clotting disorders. 7. Has ABI \<0.8 8. Subject is pregnant or breastfeeding 9. For GSV/SSV only: has a BMI \>35. 10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein). 11. Unable to ambulate, or restrictive ambulation. 12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy). 13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure. 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed