Venclose digiRF System Post Market Study

Venclose digiRF System: 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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Venous Reflux; Chronic Venous Insufficiency
• Intervention / Treatment: Device: Venclose System (digiRF generator w EVSRF catheter); Device: Venclose MAVEN System (digiRF generator w MAVEN catheter)

• Study Type: Interventional
• Enrollment (Estimated): 203
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai-Ly Wilcox; Phone Number: +14805811620; Email: Mai-Ly.Wilcox@bd.com
• Study Contact Backup: Name: Kulveen Dhatt; Phone Number: +16028305365; Email: kulveen.dhatt@bd.com

Study Locations

• United States
  • Hawaii
    • Kailua, Hawaii, United States, 96740
      • Pacific Vascular Institute
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Eastlake Cardiovascular
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSV/SSV; Incompetent Great and Small Saphenous Veins	Device: 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.
Experimental: IPV; Incompetent Perforator Veins	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
revised Venous Clinical Severity Score (rVCSS)	Distribution of rVCSS score	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)	Distribution of CIVIQ-20 score	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)	Distribution of CEAP clinical class	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)	Distribution of VAS Pain score	Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
Recanalization	Proportion of Recanalization of treated veins	1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
Duration of Procedure	Mean Duration of Procedure	Day 1 Index Procedure visit
Endovenous Heat Induced Thrombosis (2-4)	Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4	1-Month (+7 days) visit

Collaborators and Investigators

• Sponsor: C. R. Bard

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: BDPI-21-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No