Clinical trial NCT01570101: European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
Official title: Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency of Leg
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative Duplex Ultrasound
timeFrame: Immediately Post-procedure
Secondary outcomes:
measure: Safety
timeFrame: Immediately post-op through 6 month Follow-up "FU"
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Aareknudeklinikken
city: Hamburg
country: Germany
facility: Dermatologikum
city: Mannheim
country: Germany
facility: Klinik Proebstle
city: Alkmaar
country: Netherlands
facility: Centrum Oosterawal
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Klinik Proebstlé
name: Thomas Proebstle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proebstle T, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies AH. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):329-334. doi: 10.1016/j.jvsv.2020.05.019. Epub 2020 Jun 26.
citation: Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.