Clinical trial NCT05504070: Venclose digiRF System Post Market Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Venous Reflux
Chronic Venous Insufficiency
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occlusion
timeFrame: 1-Month
measure: DVT & PE Serious Adverse Events
timeFrame: 1-Month
Secondary outcomes:
measure: revised Venous Clinical Severity Score (rVCSS)
timeFrame: 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
measure: ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)
timeFrame: Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits
measure: Clinical Etiological Anatomical Pathophysiological (CEAP)
timeFrame: 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
measure: Visual Analog Scale for Pain (VAS)
timeFrame: Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits
measure: Recanalization
timeFrame: 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits
measure: Duration of Procedure
timeFrame: Day 1 Index Procedure visit
measure: Endovenous Heat Induced Thrombosis (2-4)
timeFrame: 1-Month (+7 days) visit
Other outcomes:
Locations:
city: Kailua
country: United States
facility: Pacific Vascular Institute
state: Hawaii
city: Roseville
country: United States
facility: Eastlake Cardiovascular
state: Michigan
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
Study officials:
References: