Venous Insufficiency of Leg
Conditions
Brief summary
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting.
Detailed description
This is a post market, observational study of closure of the great saphenous vein GSV. Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
Interventions
DEVICECE Marked Sapheon Closure System
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and ≤ 70 years of age. * Symptomatic primary Great Saphenous Vein GSV incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging. * CEAP classification of C2, C3 or C4. * 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 Ultrasound ≥3mm and ≤10mm (maximum diameter).
Exclusion criteria
* Life expectancy \< 1 year. * Regular pain medication. * Anticoagulation including Heparin or Coumadin. * Previous Deep Vein Thrombosis DVT. * Previous superficial thrombophlebitis in GSV. * Previous venous treatment on target limb. * Known Hyper-coagulable disorder. * Conditions which prevent routine vein treatment like: * Acute disease, * Immobilization or inability to ambulate, and * Pregnancy. * Tortuous GSV, which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed). * Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein. * Known sensitivity to the cyanoacrylate CA adhesive. * Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Duplex Ultrasound | Immediately Post-procedure | The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Immediately post-op through 6 month Follow-up FU | The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious). |
Countries
Denmark, Germany, Netherlands, United Kingdom
Outcome results
None listed