European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Not Applicable

Completed

• Conditions: Venous Insufficiency of Leg
• Interventions: Device: CE Marked Sapheon Closure System

• Registration Number: NCT01570101
• Lead Sponsor: Medtronic Endovascular

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-04
• Primary Completion: 2013-07
• Study Completion: 2015-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CE Marked Sapheon Closure System in GSV	CE Marked Sapheon Closure System	CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

Aareknudeklinikken; 🇩🇰 Naestved, Denmark

Dermatologikum; 🇩🇪 Hamburg, Germany

Klinik Proebstle; 🇩🇪 Mannheim, Germany

Centrum Oosterawal; 🇳🇱 Alkmaar, Netherlands

Countess of Chester Hospital NHS Foundation Trust; 🇬🇧 Chester, United Kingdom

The Whiteley Clinic; 🇬🇧 Guildford, United Kingdom

Charing Cross Hospital; 🇬🇧 London, United Kingdom