NCT03722134

Brief Summary

Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

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

January 31, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 10, 2021

Status Verified

October 1, 2018

Enrollment Period

6.9 years

First QC Date

October 23, 2018

Last Update Submit

February 8, 2021

Conditions

Varicose Veins of Lower Limb

Keywords

Great saphenous veinThermal ablationMechanochemical ablationRandomized controlled trial

Outcome Measures

Primary Outcomes (9)

  • Occlusion rate

    Occlusion rate of the great saphenous vein

    One year after the treatment

  • Freedom from reflux

    The absence of reflux in the treated great saphenous vein

    One year after the treatment

  • Disease-specific quality of life

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

    One year after the treatment

  • Occlusion rate

    Occlusion rate of the great saphenous vein

    three years after the treatment

  • Freedom from reflux

    The absence of reflux in the treated great saphenous vein

    three years after the treatment

  • Disease-specific quality of life

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

    three years after the treatment

  • Occlusion rate

    Occlusion rate of the great saphenous vein

    five years after the treatment

  • Freedom from reflux

    The absence of reflux in the treated great saphenous vein

    five years after the treatment

  • Disease-specific quality of life

    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

    five years after the treatment

Secondary Outcomes (5)

  • Peroperative and immediate postoperative pain

    During the procedure, immediately after, and at one week after the treatment

  • Sick leave

    During the immediate postoperative period up to one month

  • Pain medication

    During the immediate postoperative period up to one month

  • 30-day occlusion rate

    30 days after the treatment

  • Complications

    Up to five years after the treatment

Study Arms (3)

MOCA

EXPERIMENTAL

The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).

Procedure: MOCA

EVLA

ACTIVE COMPARATOR

The refluxing GSV was treated with endovenous laser ablation.

Procedure: EVLA

RFA

ACTIVE COMPARATOR

The refluxing GSV was treated with radiofrequency ablation.

Procedure: RFA

Interventions

MOCAPROCEDURE

Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.

MOCA
EVLAPROCEDURE

Great saphenous vein occlusion with a thermal laser chateter

EVLA
RFAPROCEDURE

Great saphenous vein occlusion with a thermal radiofrequency chateter

RFA

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical classification of venous disease C2-C4
  • ultrasound-verified reflux in the GSV
  • mean GSV diameter in the thigh between 5 and 12 millimetres
  • informed consent.

You may not qualify if:

  • body mass index (BMI) of over 40
  • peripheral arterial disease
  • lymphoedema
  • pregnancy
  • allergy to either the sclerosant or lidocaine
  • severe general illness
  • malignancy
  • previous deep venous thrombosis
  • previous varicose vein intervention in the same leg
  • coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vahaaho S, Halmesmaki K, Mahmoud O, Alback A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):652-659. doi: 10.1016/j.jvsv.2020.08.007. Epub 2020 Aug 12.

    PMID: 32795619DERIVED

  • Vahaaho S, Mahmoud O, Halmesmaki K, Alback A, Noronen K, Vikatmaa P, Aho P, Venermo M. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019 Apr;106(5):548-554. doi: 10.1002/bjs.11158.

    PMID: 30908611DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Our study aim was to assess the applicability and safety of MOCA in short term as well as occlusion rate and disease specific quality of life one year after the procedure, and compare it with currently used thermal ablation methods of laser ablation (EVLA) and radiofrequency ablation (RFA) in a randomized controlled trial. Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Surgery

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 26, 2018

Study Start

January 31, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 10, 2021

Record last verified: 2018-10