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
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
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
NCT ID
NCT03722134
First Posted
October 23, 2018
Last Updated
February 8, 2021
Sponsor
Helsinki University Central Hospital
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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