European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

Last updated: April 29, 2016
Sponsor: Medtronic Endovascular
Overall Status: Completed

Phase

N/A

Condition

Deep Vein Thrombosis

Varicose Veins

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01570101
CP-10763-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years and ≤ 70 years of age.

  • Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinicalsymptoms, with or without visible varicosities, and confirmed by duplex ultrasoundimaging.

  • 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 informedconsent.

  • "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).

Exclusion

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 catheterplacement. (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 ortreatment, or within the 30 days prior to enrollment.

Study Design

Total Participants: 70
Study Start date:
December 01, 2011
Estimated Completion Date:
September 30, 2015

Study 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.

Connect with a study center

  • Aareknudeklinikken

    Naestved, 4700
    Denmark

    Site Not Available

  • Dermatologikum

    Hamburg, 20354
    Germany

    Site Not Available

  • Klinik Proebstle

    Mannheim, D - 68161
    Germany

    Site Not Available

  • Centrum Oosterawal

    Alkmaar,
    Netherlands

    Site Not Available

  • Countess of Chester Hospital NHS Foundation Trust

    Chester, CH2 1UL
    United Kingdom

    Site Not Available

  • The Whiteley Clinic

    Guildford, GU2 7RF
    United Kingdom

    Site Not Available

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Site Not Available

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