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European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study (eSCOPE)

Primary Purpose

Venous Insufficiency of Leg

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CE Marked Sapheon Closure System
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency of Leg

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aareknudeklinikken
  • Dermatologikum
  • Klinik Proebstle
  • Centrum Oosterawal
  • Countess of Chester Hospital NHS Foundation Trust
  • The Whiteley Clinic
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CE Marked Sapheon Closure System in GSV

Arm Description

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

Outcomes

Primary Outcome Measures

Comparative Duplex Ultrasound
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

Safety
The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).

Full Information

First Posted
March 26, 2012
Last Updated
April 29, 2016
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01570101
Brief Title
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
Acronym
eSCOPE
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency of Leg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CE Marked Sapheon Closure System in GSV
Arm Type
Experimental
Arm Description
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Intervention Type
Device
Intervention Name(s)
CE Marked Sapheon Closure System
Intervention Description
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Primary Outcome Measure Information:
Title
Comparative Duplex Ultrasound
Description
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.
Time Frame
Immediately Post-procedure
Secondary Outcome Measure Information:
Title
Safety
Description
The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
Time Frame
Immediately post-op through 6 month Follow-up "FU"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Proebstle, MD
Organizational Affiliation
Klinik Proebstlé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aareknudeklinikken
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Dermatologikum
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Klinik Proebstle
City
Mannheim
ZIP/Postal Code
D - 68161
Country
Germany
Facility Name
Centrum Oosterawal
City
Alkmaar
Country
Netherlands
Facility Name
Countess of Chester Hospital NHS Foundation Trust
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
The Whiteley Clinic
City
Guildford
ZIP/Postal Code
GU2 7RF
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32599306
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.
Results Reference
derived
PubMed Identifier
26993674
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.
Results Reference
derived

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European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

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