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Mechanochemical Ablation vs Thermal Ablation

Primary Purpose

Varicose Veins of Lower Limb

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MOCA
EVLA
RFA
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    MOCA

    EVLA

    RFA

    Arm Description

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

    The refluxing GSV was treated with endovenous laser ablation.

    The refluxing GSV was treated with radiofrequency ablation.

    Outcomes

    Primary Outcome Measures

    Occlusion rate
    Occlusion rate of the great saphenous vein
    Freedom from reflux
    The absence of reflux in the treated great saphenous vein
    Disease-specific quality of life
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
    Occlusion rate
    Occlusion rate of the great saphenous vein
    Freedom from reflux
    The absence of reflux in the treated great saphenous vein
    Disease-specific quality of life
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
    Occlusion rate
    Occlusion rate of the great saphenous vein
    Freedom from reflux
    The absence of reflux in the treated great saphenous vein
    Disease-specific quality of life
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

    Secondary Outcome Measures

    Peroperative and immediate postoperative pain
    Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain)
    Sick leave
    Number of sick leave days necessary after the treatment
    Pain medication
    The amount and type of pain medication received during and after the treatment
    30-day occlusion rate
    The occlusion rate of the treated great saphenous vein
    Complications
    All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment

    Full Information

    First Posted
    October 23, 2018
    Last Updated
    February 8, 2021
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03722134
    Brief Title
    Mechanochemical Ablation vs Thermal Ablation
    Official Title
    Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 31, 2014 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    December 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study. Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV. The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh. During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure. At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicose Veins of Lower Limb
    Keywords
    Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    132 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MOCA
    Arm Type
    Experimental
    Arm Description
    The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).
    Arm Title
    EVLA
    Arm Type
    Active Comparator
    Arm Description
    The refluxing GSV was treated with endovenous laser ablation.
    Arm Title
    RFA
    Arm Type
    Active Comparator
    Arm Description
    The refluxing GSV was treated with radiofrequency ablation.
    Intervention Type
    Procedure
    Intervention Name(s)
    MOCA
    Intervention Description
    Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
    Intervention Type
    Procedure
    Intervention Name(s)
    EVLA
    Intervention Description
    Great saphenous vein occlusion with a thermal laser chateter
    Intervention Type
    Procedure
    Intervention Name(s)
    RFA
    Intervention Description
    Great saphenous vein occlusion with a thermal radiofrequency chateter
    Primary Outcome Measure Information:
    Title
    Occlusion rate
    Description
    Occlusion rate of the great saphenous vein
    Time Frame
    One year after the treatment
    Title
    Freedom from reflux
    Description
    The absence of reflux in the treated great saphenous vein
    Time Frame
    One year after the treatment
    Title
    Disease-specific quality of life
    Description
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
    Time Frame
    One year after the treatment
    Title
    Occlusion rate
    Description
    Occlusion rate of the great saphenous vein
    Time Frame
    three years after the treatment
    Title
    Freedom from reflux
    Description
    The absence of reflux in the treated great saphenous vein
    Time Frame
    three years after the treatment
    Title
    Disease-specific quality of life
    Description
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
    Time Frame
    three years after the treatment
    Title
    Occlusion rate
    Description
    Occlusion rate of the great saphenous vein
    Time Frame
    five years after the treatment
    Title
    Freedom from reflux
    Description
    The absence of reflux in the treated great saphenous vein
    Time Frame
    five years after the treatment
    Title
    Disease-specific quality of life
    Description
    Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
    Time Frame
    five years after the treatment
    Secondary Outcome Measure Information:
    Title
    Peroperative and immediate postoperative pain
    Description
    Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain)
    Time Frame
    During the procedure, immediately after, and at one week after the treatment
    Title
    Sick leave
    Description
    Number of sick leave days necessary after the treatment
    Time Frame
    During the immediate postoperative period up to one month
    Title
    Pain medication
    Description
    The amount and type of pain medication received during and after the treatment
    Time Frame
    During the immediate postoperative period up to one month
    Title
    30-day occlusion rate
    Description
    The occlusion rate of the treated great saphenous vein
    Time Frame
    30 days after the treatment
    Title
    Complications
    Description
    All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment
    Time Frame
    Up to five years after the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32795619
    Citation
    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. Erratum In: J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):981.
    Results Reference
    derived
    PubMed Identifier
    30908611
    Citation
    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.
    Results Reference
    derived

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    Mechanochemical Ablation vs Thermal Ablation

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