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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05504070
Other study ID # BDPI-21-006
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 8, 2023
Est. completion date June 2027

Study information

Verified date January 2024
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 203
Est. completion date June 2027
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
United States Englewood Hospital Englewood New Jersey
United States Pacific Vascular Institute Kailua Hawaii
United States Eastlake Cardiovascular Roseville Michigan

Sponsors (1)

Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occlusion Cumulative Incidence of Occlusion 1-Month
Primary DVT & PE Serious Adverse Events Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events 1-Month
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Duration of Procedure Mean Duration of Procedure Day 1 Index Procedure visit
Secondary 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
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