VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Oct 30, 2027
  • participants needed
    806
  • sponsor
    Medtronic Endovascular
Updated on 10 March 2022
Investigator
Salem Arefe
Primary Contact
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (4.8 mi away) Contact
+23 other location

Summary

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Description

The study is designed with two randomized studies and one single arm study.

Two randomized studies are for CEAP 2-5 subjects:

  1. VenaSeal vs. Surgical Stripping Study (outside of the United States only)
  2. VenaSeal vs. ETA Study

The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU):

  1. VLU Study

Details
Condition Venous Reflux
Treatment Surgical stripping, VenaSeal™ Closure System, Endothermal Ablation (ETA)
Clinical Study IdentifierNCT03820947
SponsorMedtronic Endovascular
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is ≥18 years of age
Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by DUS
Eligibility for treatment
VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA
VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping
VLU Study: patients should be eligible for treatment with the VenaSeal™ system
Treatable refluxing segment of target vein(s) 10 cm in length or longer
Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
Patient is willing and capable of complying with specified follow-up evaluations at the specified times
Patient has an ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria

Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
Patient has abnormal pulse exam or ABI <0.8
Patient has acute superficial thrombophlebitis
Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
IFU contraindications
VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s)
VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)
VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
Patient is non-ambulatory
Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures
Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study
Patient has documented or suspected (by a clinician) COVID-19 infection currently or within the past 6 months
VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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