Venclose digiRF System Post Market Study

C. R. Bard

Status: Invitation-only

Conditions: Venous Reflux; Chronic Venous Insufficiency

Treatments: Device: Venclose MAVEN System (digiRF generator w MAVEN catheter); Device: Venclose System (digiRF generator w EVSRF catheter)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504070

BDPI-21-006

Details and patient eligibility

About

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.

Enrollment: 203 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

GSV/SSV

Experimental group

Description:

Incompetent Great and Small Saphenous Veins

Treatment:

Device: Venclose System (digiRF generator w EVSRF catheter)

IPV

Experimental group

Description:

Incompetent Perforator Veins

Treatment:

Device: Venclose MAVEN System (digiRF generator w MAVEN catheter)