Venclose digiRF System Post Market Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2027-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Venous Reflux Chronic Venous Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSV/SSV

Incompetent Great and Small Saphenous Veins

Group Type EXPERIMENTAL

Venclose System (digiRF generator w EVSRF catheter)

Intervention Type DEVICE

The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.

IPV

Incompetent Perforator Veins

Group Type EXPERIMENTAL

Venclose MAVEN System (digiRF generator w MAVEN catheter)

Intervention Type DEVICE

The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.

Interventions

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Venclose 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.

Intervention Type DEVICE

Venclose 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No