Mechanochemical Ablation vs Thermal Ablation

Varicose Veins of Lower Limb Clinical Trial

Official title:

Mechanochemical Ablation vs Thermal Ablation in Patients With Great Saphenous Vein Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722134
• Other study ID #: Clarivein RCT
• Status: Completed
• Phase: N/A
• Start date: January 31, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The main outcome measure was the occlusion rate of the GSV at one and three years.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Procedure:
• MOCA
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
• EVLA
Great saphenous vein occlusion with a thermal laser chateter
• RFA
Great saphenous vein occlusion with a thermal radiofrequency chateter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion rate	Occlusion rate of the great saphenous vein	One year after the treatment
Primary	Freedom from reflux	The absence of reflux in the treated great saphenous vein	One year after the treatment
Primary	Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	One year after the treatment
Primary	Occlusion rate	Occlusion rate of the great saphenous vein	three years after the treatment
Primary	Freedom from reflux	The absence of reflux in the treated great saphenous vein	three years after the treatment
Primary	Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	three years after the treatment
Primary	Occlusion rate	Occlusion rate of the great saphenous vein	five years after the treatment
Primary	Freedom from reflux	The absence of reflux in the treated great saphenous vein	five years after the treatment
Primary	Disease-specific quality of life	Quality of life as measured by the Aberdeen Varicose Veins Questionnaire	five years after the treatment
Secondary	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)	During the procedure, immediately after, and at one week after the treatment
Secondary	Sick leave	Number of sick leave days necessary after the treatment	During the immediate postoperative period up to one month
Secondary	Pain medication	The amount and type of pain medication received during and after the treatment	During the immediate postoperative period up to one month
Secondary	30-day occlusion rate	The occlusion rate of the treated great saphenous vein	30 days after the treatment
Secondary	Complications	All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment	Up to five years after the treatment