Venclose digiRF System Post Market Study

Not Applicable

• Conditions: Chronic Venous Insufficiency; Venous Reflux
• Interventions: Device: Venclose MAVEN System (digiRF generator w MAVEN catheter); Device: Venclose System (digiRF generator w EVSRF catheter)

• Registration Number: NCT05504070
• Lead Sponsor: C. R. Bard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2023-09-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPV	Venclose MAVEN System (digiRF generator w MAVEN catheter)	Incompetent Perforator Veins
GSV/SSV	Venclose System (digiRF generator w EVSRF catheter)	Incompetent Great and Small Saphenous Veins

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Duration of Procedure	Day 1 Index Procedure visit	Mean Duration of Procedure
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
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
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

Trial Locations

Locations (3)

Pacific Vascular Institute; 🇺🇸 Kailua, Hawaii, United States

Englewood Hospital; 🇺🇸 Englewood, New Jersey, United States

Eastlake Cardiovascular; 🇺🇸 Roseville, Michigan, United States