NCT02454452

Brief Summary

Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

May 22, 2015

Last Update Submit

August 17, 2017

Conditions

Varicose Veins

Keywords

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • Absence of venous reflux

    Absence of venous reflux by duplex ultrasound

    2 years

Secondary Outcomes (4)

  • CIVIQ

    2 years

  • SF-36

    2 years

  • VCSS

    2 years

  • Surgical complications

    1 month

Study Arms (3)

Saphenous vein stripping

ACTIVE COMPARATOR

Saphenous venous stripping surgical technique

Procedure: Saphenous vein stripping

CHIVA

ACTIVE COMPARATOR

conservative hemodynamic treatment venous insufficiency (CHIVA)

Procedure: CHIVA

Radiofrequency

EXPERIMENTAL

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Procedure: Radiofrequency

Interventions

RadiofrequencyPROCEDURE

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Radiofrequency
Saphenous vein strippingPROCEDURE

Saphenous vein stripping

Saphenous vein stripping
CHIVAPROCEDURE

conservative hemodynamic treatment venous insufficiency

CHIVA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
  • Age \> 18 years
  • Informed consent

You may not qualify if:

  • Recurrent varicose veins
  • Post-thrombotic syndrome.
  • Patients with active malignancies or severe ischemic heart disease.
  • Serious liver disease
  • Thrombophilia.
  • Serious psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

  • Gonzalez Canas E, Florit Lopez S, Vilagut RV, Guevara-Noriega KA, Santos Espi M, Rios J, Soto SN, Gimenez Gaibar A. A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):101-112. doi: 10.1016/j.jvsv.2020.04.019. Epub 2020 Apr 28.

    PMID: 32353592DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Elena González Cañas, MD

    Corporacion Parc Taulí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 27, 2015

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

ES(1)