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Active, not recruiting Not applicable

Venclose digiRF System Post Market Study

NCT05504070 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Not applicable
Started
2023-09-08
Last updated
2026-03-18

Condition(s) studied

Venous RefluxChronic Venous Insufficiency

Investigational drug(s) / intervention(s)

Venclose System (digiRF generator w EVSRF catheter)Venclose MAVEN System (digiRF generator w MAVEN catheter)

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (7)

FacilityCityRegionStatus
ClinRe Thornton Colorado
Pacific Vascular Institute Kailua Hawaii
Eastlake Cardiovascular Roseville Michigan
Englewood Hospital Englewood New Jersey
Atrium Health Charlotte North Carolina
Christus Health Tyler Texas
ClinRe Colonial Heights Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05504070 on ClinicalTrials.gov ↗ ← All trials in the USA