Venclose digiRF System Post Market Study

Launched by C. R. BARD · Aug 15, 2022

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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.