VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
NCT ID: NCT03820947
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
506 participants
INTERVENTIONAL
2020-02-05
2025-11-10
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping
CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System
VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Interventions
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VenaSeal™ System
The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. 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
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. 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
6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times
7. Patient has an ability to understand the requirements of the study and to provide informed consent
Exclusion Criteria
2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
3. Patient has abnormal pulse exam or ABI \<0.8
4. Patient has acute superficial thrombophlebitis
5. 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
6. 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)
7. 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)
8. Patient is non-ambulatory
9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure
10. 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
11. 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
12. 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.
13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory
14. 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)
18 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Kathleen Gibson, MD
Role: PRINCIPAL_INVESTIGATOR
Lake Washington Vascular, US
Manjit Gohel, MD
Role: PRINCIPAL_INVESTIGATOR
Addenbrooke's Hospital, UK
Locations
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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
Padua, , 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
Gangnam Severance Hospital
Seoul, , South Korea
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)
Granada, , Spain
Sanitas Hospital Universitario La Zarzuela
Madrid, , Spain
Bedfordshire Hospitals NHS Foundation Trust
Bedford, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, , United Kingdom
West London Vascular and Interventional Centre
Harrow, , United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT18034
Identifier Type: -
Identifier Source: org_study_id