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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722134
Other study ID # Clarivein RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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