Mechanochemical Ablation vs Thermal Ablation

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03722134
• Collaborator: (none)
• Enrollment: 132
• Arms: 3
• Actual Duration (Months): 83

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins of Lower Limb	Procedure: MOCA; Procedure: EVLA; Procedure: RFA	N/A

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

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency
• Actual Study Start Date: Jan 31, 2014
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MOCA The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).	Procedure: MOCA; Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
Active Comparator: EVLA The refluxing GSV was treated with endovenous laser ablation.	Procedure: EVLA; Great saphenous vein occlusion with a thermal laser chateter
Active Comparator: RFA The refluxing GSV was treated with radiofrequency ablation.	Procedure: RFA; Great saphenous vein occlusion with a thermal radiofrequency chateter

Outcome Measures

Primary Outcome Measures

1. Occlusion rate [One year after the treatment]

   Occlusion rate of the great saphenous vein

2. Freedom from reflux [One year after the treatment]

   The absence of reflux in the treated great saphenous vein

3. Disease-specific quality of life [One year after the treatment]

   Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

4. Occlusion rate [three years after the treatment]

   Occlusion rate of the great saphenous vein

5. Freedom from reflux [three years after the treatment]

   The absence of reflux in the treated great saphenous vein

6. Disease-specific quality of life [three years after the treatment]

   Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

7. Occlusion rate [five years after the treatment]

   Occlusion rate of the great saphenous vein

8. Freedom from reflux [five years after the treatment]

   The absence of reflux in the treated great saphenous vein

9. Disease-specific quality of life [five years after the treatment]

   Quality of life as measured by the Aberdeen Varicose Veins Questionnaire

Secondary Outcome Measures

1. Peroperative and immediate postoperative pain [During the procedure, immediately after, and at one week after the treatment]

   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)

2. Sick leave [During the immediate postoperative period up to one month]

   Number of sick leave days necessary after the treatment

3. Pain medication [During the immediate postoperative period up to one month]

   The amount and type of pain medication received during and after the treatment

4. 30-day occlusion rate [30 days after the treatment]

   The occlusion rate of the treated great saphenous vein

5. Complications [Up to five years after the treatment]

   All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Helsinki University Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT03722134
• Other Study ID Numbers: Clarivein RCT
• First Posted: Oct 26, 2018
• Last Update Posted: Feb 10, 2021
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital: Great saphenous vein; Thermal ablation; Mechanochemical ablation; Randomized controlled trial
• Additional relevant MeSH terms: Varicose Veins

Study Results

No Results Posted as of Feb 10, 2021