Venous Incompetence ( valve leakage) of the great saphenous vein
Conditions
Interventions
None listed
Sponsors
Sapheon Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age *18 years and * 70 years of age. * Symptomatic primary GSV incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging. * CEAP classification of C2, C3 or C4 (see Appendix 10). * Ability to walk unassisted. * Ability to attend follow-up visits. * Ability to understand the requirements of the study and to provide written informed consent. * GSV on standing pre-procedure Doppler US *3mm and *10mm (maximum diameter).
Exclusion criteria
Exclusion criteria: * Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is an observational study on an approved device. Efficacy and safety (adverse events) will be compared with appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System (SCS) Kit are consistent with or not inferior than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. * The Primary endpoint is duplex ultrasound proven great saphenous vein closure with lack of pathological reflux at prescribed intervals. Efficacy: The ability of the Sapheon Closure System (SCS) Kit to treat venous reflux by closing the great saphenous vein. During the procedure, the primary measures are defined as follows: * Procedural Success (complete closure) * vein closure along the entire treated vein segment due to the initial Sapheon Closure System directed administration of the Sapheon Closure Adhesive (SCA). No discrete segments of patency * 10cm. * Procedural Failure * inability to attain vein closure during the procedure with discrete segments of patency > 10 cm. At all follow-up, the primary efficacy measures are: * Complete Closure * Duplex ultrasound proven vein closure along the entire treated vein segment due to the initial Sapheon Closure System directed administration of the Sapheon Closure Adhesive (SCA). No discrete segments of patency * 10cm. * Recanalization/Patency * significant recanalization/patency in a treated vein that was previously closed or partially closed, or was an initial procedural failure and has discrete segments of >10cm of patency | — |
Secondary
| Measure | Time frame |
|---|---|
| 7.2 Secondary Endpoints * The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious). Safety: Evaluation of safety will be accomplished by carefully monitoring and recording the incidence of adverse events during the procedure, immediately after the procedure, and during a 6-month follow-up period which includes follow-up visits 24-72 hours, and 1, 3, and 6 months post procedure. 7.3 Third Endpoint Quality of life and pain * Patient satisfaction and Quality of Life measured by EQ5D, AVVQ and Adverse reactions, at prescribed time periods pre- and post-procedure (see Table 1). * Venous Clinical Severity Score at prescribed time periods pre- and post-procedure (see Table 1). * Pain during the procedure, diary (VAS) on use of analgesics, at proscribed time periods pre- and post-procedure (see Table 1). Pain reported during the first 30 days by patient diary VAS. | — |
Countries
Netherlands
Outcome results
None listed