VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Stopped early · Not applicable

Conditions studied: Venous Reflux

In brief

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

Key facts

Study ID

NCT03820947

Run by

Medtronic Endovascular

People needed

506

Starts

2020-02-05

Expected to finish

2025-11-10

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Duplex Ultrasound (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

You may not qualify if…

• 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 COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion.
• 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)

Where it is running

• Yavapai Regional Medical Center — Prescott Valley, Arizona, United States
• PIMA Heart and Vascular — Tucson, Arizona, United States
• Valley Vascular Surgical Associates — Fresno, California, United States
• Vascular Care Connecticut — Darien, Connecticut, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Vascular Care Group — Wellesley, Massachusetts, United States
• New York-Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Orion Medical — Houston, Texas, United States
• Lake Washington Vascular — Bellevue, Washington, United States
• Sunshine Coast University Hospital — Birtinya, Australia
• Wollongong Hospital — Wollongong, Australia
• East Toronto Vascular Clinic — Toronto, Ontario, Canada
• CHU Dijon Bourgogne — Dijon, DIjon Cedex, France
• Clinique du Parc — Lyon, France
• Clinique Pasteur — Toulouse, France
• Praxis fur Innere Medizin und Gefäβkrankheiten — Halle, Germany
• Ospedale Fatebenefratelli e Oftalmico — Milan, Italy
• Azienda Ospedaliera di Padova Ospendale Sant' Antonio — Padova, Italy
• Rijnstate - Locatie Arnhem — Arnhem, Netherlands
• Seoul National University Hospital — Seoul, South Korea
• Seoul Saint Mary's Hospital — Seoul, South Korea
• Konkuk University Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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