Venclose digiRF System Post Market Study

Launched by C. R. BARD · Aug 15, 2022

Keywords

ClinConnect Summary

This is a post-market, multi-center study (not a randomized trial) looking at how well the Venclose system works to treat chronic venous disease in the legs. It tests two devices: the Venclose EVSRF catheter for treating large and small saphenous veins that aren’t working well, and the Venclose MAVEN catheter for treating incompetent perforator veins. The study has only one group (all participants receive the device) and will enroll about 203 adults who have symptoms and vein reflux caused by the great/small saphenous veins or perforator veins. To be eligible, participants must be 18 or older, have at least CEAP class C2 disease, and have veins with specific reflux and size criteria. People with recent blood clots, major bleeding risks, pregnancy, significant limb artery problems, or certain prior vein treatments in the target leg would not be eligible.

If you participate, you’ll undergo the Venclose procedure and then attend follow-up visits over two years. The main things the study will look at are whether the treated veins stay closed (occlusion) at about one month after the procedure, and whether there are any serious blood clotting problems like deep vein thrombosis or pulmonary embolism related to the device or procedure. Secondary checks include how your leg symptoms and quality of life change over time, pain levels, how often the veins reopen, how long the procedure takes, and any other safety issues such as blood clots near the treated area. The study is sponsored by C. R. Bard and is conducted at several U.S. sites; results are not yet available.

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.