European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Medtronic

Status

Completed

Conditions

Venous Insufficiency of Leg

Treatments

Device: CE Marked Sapheon Closure System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01570101

CP-10763-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.