NCT02397226

Brief Summary

200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2014Dec 2026

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

7.2 years

First QC Date

March 12, 2015

Last Update Submit

December 3, 2024

Conditions

Varicose VeinsVenous Insufficiency

Keywords

Radiofrequency ablationPlethysmographyDuplex ultrasoundHigh ligation/stripping

Outcome Measures

Primary Outcomes (3)

  • Number of treated veins with recanalization using duplex.

    Flow detected by duplex at the site of the treated vein.

    5 years

  • Number of treated limbs with neovascularization using duplex and/or plethysmography.

    5 years

  • Prediction of treatment outcome using plethysmography with superficial shut-down.

    If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.

    1 month postoperatively

Secondary Outcomes (3)

  • VCSS score

    5 years

  • AVVQ score

    5 years

  • EQ-5D score

    5 years

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.

Procedure: Radiofrequency ablationDevice: Radiofrequency ablation catheterProcedure: Tumescent anesthesia

High ligation/stripping

ACTIVE COMPARATOR

Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.

Procedure: High ligation/strippingProcedure: General anesthesiaDevice: Vein stripping catheter

Interventions

Radiofrequency ablationPROCEDURE
Radiofrequency ablation
High ligation/strippingPROCEDURE
Also known as: Open surgery
High ligation/stripping
Radiofrequency ablation catheterDEVICE
Also known as: Covidien ClosureFast Catheter (7cm)
Radiofrequency ablation
Tumescent anesthesiaPROCEDURE
Radiofrequency ablation
General anesthesiaPROCEDURE
High ligation/stripping
Vein stripping catheterDEVICE
High ligation/stripping

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Insufficient great saphenous vein
  • Possible to treat with both radiofrequency ablation and high ligation/stripping
  • Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

You may not qualify if:

  • Previous intervention in the affected leg
  • Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
  • Small saphenous vein insufficiency with diameter \>6 mm and/or flow \>100ml/min
  • Patient that is not able to perform plethysmography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Linköping

Linköping, Östergötland County, 58185, Sweden

Location

Vrinnevisjukhuset

Norrköping, Östergötland County, 60379, Sweden

Location

Related Publications (1)

  • Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20.

    PMID: 31959059DERIVED

MeSH Terms

Conditions

Varicose VeinsVenous Insufficiency

Interventions

Radiofrequency AblationConversion to Open SurgeryCatheter AblationAnesthesia, General

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeEndoscopyMinimally Invasive Surgical ProceduresAnesthesiaAnesthesia and Analgesia

Study Officials

  • Helene Zachrisson, Associate Professor, MD

    Linkoeping University

    STUDY CHAIR

  • Oskar Nelzén, MD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

September 1, 2014

Primary Completion

November 25, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

SE(2)