Venclose digiRF System Post Market Study

NCT05504070 | Active Not Recruiting FDA Device

• 1 other identifier: BDPI-21-006
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 7

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.

Conditions

Venous Reflux; Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• Occlusion

  Cumulative Incidence of Occlusion

  1-Month

• DVT & PE Serious Adverse Events

  Cumulative Incidence of Device and Procedural Related Deep venous thrombosis \& Pulmonary Embolism Serious Adverse Events

  1-Month

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• Recanalization

  1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits

Study Arms (2)

GSV/SSV

EXPERIMENTAL

Incompetent Great and Small Saphenous Veins

Device: Venclose System (digiRF generator w EVSRF catheter)

IPV

EXPERIMENTAL

Incompetent Perforator Veins

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

Interventions

Venclose System (digiRF generator w EVSRF catheter) DEVICE

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

GSV/SSV

Venclose MAVEN System (digiRF generator w MAVEN catheter) DEVICE

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

IPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is age 18 and older
• Subject has CEAP clinical class C2 and higher.
• Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
• 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.
• For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
• For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
• For IPV only: IPVs must be located under a healed or active ulcer.
• Is able to ambulate.
• Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
• Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

You may not qualify if:

• Has had previous treatment for venous insufficiency in the same target vein.
• Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
• Has thrombus in the vein segment to be treated.
• Has untreated critical limb ischemia from peripheral arterial disease.
• 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.
• Subjects with known bleeding and/or clotting disorders.
• Has ABI \<0.8
• Subject is pregnant or breastfeeding
• For GSV/SSV only: has a BMI \>35.
• For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
• Unable to ambulate, or restrictive ambulation.
• Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
• Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (7)

ClinRe

Thornton, Colorado, 80602, United States

Location

Pacific Vascular Institute

Kailua, Hawaii, 96740, United States

Location

Eastlake Cardiovascular

Roseville, Michigan, 48066, United States

Location

Englewood Hospital

Englewood, New Jersey, 07631, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Christus Health

Tyler, Texas, 75702, United States

Location

ClinRe

Colonial Heights, Virginia, 23834, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: September 8, 2023
• Primary Completion: July 17, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)