Clinical trial NCT04558957: Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
Official title: Prospective, Multi-centre Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With the Use of Flebogrif in Patients With Great Saphenous Vein Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency, CVI
Lead sponsor: Balton Sp.zo.o.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2020-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®.

The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.


Eligibility criteria: Study inclusion criteria:

1. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
2. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
3. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
4. Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ)
5. Diameter of the treated vein of 4-10 mm
6. No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records
7. No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination
8. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
9. No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
10. No clinical data indicating recent thrombosis within the deep vein system
11. No clinical data on diabetes with vascular complications
12. No clinical data indicating an active neoplastic process

Study exclusion criteria:

1. Recent deep vein thrombosis or occlusion
2. Congenital disorders with associated occlusion of deep system veins
3. Pregnancy and breast-feeding
4. Lower limb ischaemia
5. Severe lymphatic oedema
6. Bleeding diatheses
7. Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation
8. Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation
9. Previous procedures on insufficiency veins of the superficial system
10. Acute infection
11. History of great saphenous vein thrombosis
12. End-stage kidney disease

Primary outcomes:
measure: Primary efficacy endpoint: Occlusion rate
timeFrame: 3 months
measure: Primary safety endpoint: Rate of SAE
timeFrame: 30 days after the procedure
Secondary outcomes:
measure: Occlusion rate
timeFrame: 1, 6, 12, 18, 24 months
measure: Number of Participants with no reflux in treated segment of the vein
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Change in quality of life by Aberdeen Varicose Vein Questionnaire
timeFrame: 12 and 24 months
measure: Clinical success - changes in rVCSS
timeFrame: 12 and 24 months
measure: Assessment of pain during the procedure
timeFrame: During procedure
measure: Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale
timeFrame: 0-7 days after procedure
measure: Assessment of the need for analgesic treatment
timeFrame: 0-7 days after procedure
measure: Period needed to resume normal activities
timeFrame: up to 2 years after the treatment
measure: Period needed to return to work (sick leave period)
timeFrame: up to 2 years after the treatment
measure: Complications rate
timeFrame: up to 2 years after the treatment
Other outcomes:
Locations:
city: Gorzów Wielkopolski
country: Poland
facility: Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii
city: Lublin
country: Poland
facility: Medyczne Centrum Nałęczów sp. z o.o.
city: Wrocław
country: Poland
facility: Klinika Dorobisz
Study officials:
References: