VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Venous Reflux

• Registration Number: NCT03820947
• Lead Sponsor: Medtronic Endovascular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-1-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Patient is =18 years of age<br><br> 2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory<br> saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for<br> treatment, as confirmed by DUS<br><br> 3. Eligibility for treatment:<br><br> - VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™<br> system and ETA<br><br> - VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with<br> the VenaSeal™ system and surgical stripping<br><br> - VLU Study: patients should be eligible for treatment with the VenaSeal™ system<br><br> 4. Treatable refluxing segment of target vein(s) 10 cm in length or longer<br><br> 5. Patient has a target vein diameter of =3 mm throughout the intended treated segment<br> of the target vein as measured by DUS while patient is standing<br><br> 6. Patient is willing and capable of complying with specified follow-up evaluations at<br> the specified times<br><br> 7. Patient has an ability to understand the requirements of the study and to provide<br> informed consent<br><br>Exclusion Criteria:<br><br> 1. Patient has a known history of allergic sensitivities (including but not limited to<br> cyanoacrylate adhesives), or any other condition, which in the opinion of the<br> investigator may make the patient more susceptible to cyanoacrylate adhesive<br> hypersensitivity<br><br> 2. Patient has known deep vein obstruction in the target limb, as identified by the<br> site's standard of care<br><br> 3. Patient has abnormal pulse exam or ABI <0.8<br><br> 4. Patient has acute superficial thrombophlebitis<br><br> 5. Patient requires any non-target vein treatments in the contralateral or ipsilateral<br> limb, or any other surgical procedure up tp 30 days pre-procedure and through 3<br> months post-procedure<br><br> 6. Patient has any co-morbid conditions, which in the investigator's opinion may<br> interfere with the patient's compliance with study visits and procedures, or may<br> confound interpretation of study data (e.g., congestive heart failure Class III and<br> IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)<br><br> 7. IFU contraindications:<br><br> - VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU<br> contraindication(s)<br><br> - VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or<br> VenaSeal™ system IFU contraindication(s)<br><br> - VLU Study: Patient has VenaSeal™ system IFU contraindication(s)<br><br> 8. Patient is non-ambulatory<br><br> 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding<br> at the time of the index procedure<br><br> 10. Patient belongs to a vulnerable population per investigator's judgment or patient<br> has any kind of disorder that compromises his/her ability to give written informed<br> consent and/or to comply with study procedures<br><br> 11. Patient is currently participating in an investigational drug or device study when<br> the data collected could be conflicting or biased due to participation in another<br> study<br><br> 12. Patient has documented COVID-19 infection currently or within the past 3 months.<br> Patient is not completely recovered from past COVID-19 infection, per physician's<br> discretion.<br><br> 13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as<br> confirmed by the independent core laboratory<br><br> 14. VLU Study: Patient has target circumferential ulceration that cannot be captured in<br> a single photograph (any ulcer curvature around the leg that goes out of sight)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study);Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study);Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study);Time to ulcer healing (For VLU study)