Varicose Veins of Lower Limb Clinical Trial
— VASCOfficial title:
V.A.S.C. (Vacuum Assisted Sclerotherapy Performed by Catheter)
NCT number | NCT05581524 |
Other study ID # | CPS01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 7, 2022 |
Est. completion date | June 2023 |
VelexTM Venous Catheter is a venous catheter for temporary use to treat a vein isolated segment, designed for the treatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy. V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study of VelexTM venous catheter used according to the indication of use within the scope of the CE mark. VelexTM venous catheter is intended for patients with varicose veins of lower limbs. The total minimum number of patients is 24 and the maximum 36 for the two centers participating. Each center shall enroll at least 8 patients andno more than 28.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age: =18 years old - Weight >45 kg - Asymptomatic or presence of at least one of the following symptoms: pain, heaviness, tiredness, itching, night cramps, restlessness, general discomfort, swelling. - GSV standing diameter between 4 and 12 mm along the whole veins (measured by Duplex ultrasound) - Willingness to undergo follow-up visits - Ability to understand scope, content and risks of the study, and provide informed consent to participation Exclusion Criteria: - Contraindications for endovascular procedures (fever, infectious processes, tumor diseases, hemorragic diathesis) - Any disease or condition contraindicating sclerotherapy treatment - Peripheral symptomatic arterial pathology (ankle brachial index ABI <0.80) - History or suspect of Deep Venous Thrombosis (DVT) or Superficial Venous Thrombosis of Great Saphenous Vein (SVT of GSV) - GSV standing diameter > 12 mm for vein segments longer than 3 cm or diameter < 4 mm for segments longer than 5 cm - Caprini score >10 - Pregnancy and breastfeeding - Previous treatments of venous pathologies in the leg (excluding telangiectasis and reticular venulas) - Allergy to sclerosant agent - Participation in another clinical trial |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Donato | Milan | |
Italy | IRCCS San Raffaele | Milan |
Lead Sponsor | Collaborator |
---|---|
I-VASC S.r.l |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use | After 3 months, patients will be asked to fill a questionnaire of quality of life. | 3 months | |
Primary | Pain level | Evaluated and recorded the pain during the procedure with the pain score scale:
Visual analogue scale (VAS) 0= NO PAIN 1-3=MILD PAIN 4-6= MODERATE/SEVERE PAIN 7-9= VERY SEVERE PAIN 10=WORST PAIN POSSIBLE |
At day 0 (day of procedure) | |
Primary | Pain level | Evaluated and recorded the pain post the procedure with the pain score scale:
Visual analogue scale (VAS) 0= NO PAIN 1-3=MILD PAIN 4-6= MODERATE/SEVERE PAIN 7-9= VERY SEVERE PAIN 10=WORST PAIN POSSIBLE |
7 days from the procedure |
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