Varicose Veins of Lower LimbNCT03722134
Mechanochemical Ablation vs Thermal Ablation
A study testing MOCA, EVLA and RFA in people with Varicose Veins of Lower Limb, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- MOCA, EVLA and RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2014to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- body mass index (BMI) of over 40
- peripheral arterial disease
- lymphoedema
- pregnancy
- allergy to either the sclerosant or lidocaine
- severe general illness
Show all 10Show fewer
- malignancy
- previous deep venous thrombosis
- previous varicose vein intervention in the same leg
- coagulation disorders
About this study
Official title: Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
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.
Read the 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.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- MOCA, EVLA, RFA
- Keywords
- Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOCAProcedure or surgery
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
EVLAProcedure or surgery
Great saphenous vein occlusion with a thermal laser chateter
RFAProcedure or surgery
Great saphenous vein occlusion with a thermal radiofrequency chateter
| Study group | Role | What they receive |
|---|---|---|
| MOCA | Experimental | The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation). Receives: Procedure: MOCA |
| EVLA | Active comparator | The refluxing GSV was treated with endovenous laser ablation. Receives: Procedure: EVLA |
| RFA | Active comparator | The refluxing GSV was treated with radiofrequency ablation. Receives: Procedure: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion rate
Occlusion rate of the great saphenous vein
Measured: One year after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Measured: One year after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Measured: One year after the treatment
Occlusion rate
Occlusion rate of the great saphenous vein
Measured: three years after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Measured: three years after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Measured: three years after the treatment
Occlusion rate
Occlusion rate of the great saphenous vein
Measured: five years after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Measured: five years after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Measured: five years after the treatment
Secondary outcomes (5)
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)
Measured: During the procedure, immediately after, and at one week after the treatment
Sick leave
Number of sick leave days necessary after the treatment
Measured: During the immediate postoperative period up to one month
Pain medication
The amount and type of pain medication received during and after the treatment
Measured: During the immediate postoperative period up to one month
30-day occlusion rate
The occlusion rate of the treated great saphenous vein
Measured: 30 days after the treatment
Complications
All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment
Measured: Up to five years after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start31 Jan 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722134
- Sponsor's protocol ID
- Clarivein RCT
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32795619Vahaaho 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.
PubMed 30908611
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
- ClinicalTrials.gov ID
- NCT03722134
- Acronym / sponsor ID
- Clarivein RCT
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| MOCA | Experimental | Procedure: MOCAThe refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation). |
| EVLA | Active comparator | Procedure: EVLAThe refluxing GSV was treated with endovenous laser ablation. |
| RFA | Active comparator | Procedure: RFAThe refluxing GSV was treated with radiofrequency ablation. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- body mass index (BMI) of over 40
- peripheral arterial disease
- lymphoedema
- pregnancy
- allergy to either the sclerosant or lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOCAGreat saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima. | Procedure or surgery | MOCA |
| EVLAGreat saphenous vein occlusion with a thermal laser chateter | Procedure or surgery | EVLA |
| RFAGreat saphenous vein occlusion with a thermal radiofrequency chateter | Procedure or surgery | RFA |
Primary outcome
Occlusion rate
Time frame: One year after the treatment
Occlusion rate of the great saphenous vein
Freedom from reflux
Time frame: One year after the treatment
The absence of reflux in the treated great saphenous vein
Disease-specific quality of life
Time frame: One year after the treatment
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Occlusion rate
Time frame: three years after the treatment
Occlusion rate of the great saphenous vein
Freedom from reflux
Time frame: three years after the treatment
The absence of reflux in the treated great saphenous vein
Disease-specific quality of life
Time frame: three years after the treatment
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Occlusion rate
Time frame: five years after the treatment
Occlusion rate of the great saphenous vein
Freedom from reflux
Time frame: five years after the treatment
The absence of reflux in the treated great saphenous vein
Disease-specific quality of life
Time frame: five years after the treatment
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
5 secondary outcomes
Peroperative and immediate postoperative pain
Time frame: During the procedure, immediately after, and at one week after the treatment
Sick leave
Time frame: During the immediate postoperative period up to one month
Pain medication
Time frame: During the immediate postoperative period up to one month
30-day occlusion rate
Time frame: 30 days after the treatment
Complications
Time frame: Up to five years after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 32795619Vahaaho 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.
- Derived from this study: PubMed 30908611Vahaaho 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MOCA, EVLA and RFA in people with Varicose Veins of Lower Limb, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion rate (time frame: One year after the treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.