506
Participants
Start Date
February 5, 2020
Primary Completion Date
June 12, 2024
Study Completion Date
April 30, 2028
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.
Sunshine Coast University Hospital, Birtinya
Rijnstate - Locatie Arnhem, Arnhem
New York-Presbyterian Hospital/Weill Cornell Medical Center, New York
Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud), Granada
Ospedale Fatebenefratelli e Oftalmico, Milan
CHU Dijon Bourgogne, Dijon
Sanitas Hospital Universitario La Zarzuela, Madrid
Azienda Ospedaliera di Padova Ospendale Sant' Antonio, Padua
OhioHealth Riverside Methodist Hospital, Columbus
Clinique du Parc, Lyon
Orion Medical, Houston
PIMA Heart and Vascular, Tucson
Valley Vascular Surgical Associates, Fresno
Yavapai Regional Medical Center, Prescott Valley
Vascular Care Connecticut, Darien
Yale School of Medicine, New Haven
Georgetown University Medical Center, Washington D.C.
Massachusetts General Hospital, Boston
Vascular Care Group, Wellesley
Lake Washington Vascular, Bellevue
Wollongong Hospital, Wollongong
Clinique Pasteur, Toulouse
Gangnam Severance Hospital, Seoul
East Toronto Vascular Clinic, Toronto
Praxis fur Innere Medizin und Gefäβkrankheiten, Halle
Seoul National University Hospital, Seoul
Seoul Saint Mary's Hospital, Seoul
Konkuk University Medical Center, Seoul
Bedfordshire Hospitals NHS Foundation Trust, Bedford
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, Cambridge
West London Vascular and Interventional Centre, Harrow
Imperial College Healthcare NHS Trust - Charing Cross Hospital, London
Lead Sponsor
Medtronic Endovascular
INDUSTRY