CompletedNot Applicable

Vacuum Assisted Sclerotherapy Performed by Catheter

Italy22 participantsStarted 2022-06-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use

Timeframe: 3 months

Pain level

Timeframe: At day 0 (day of procedure)

Pain level

Timeframe: 7 days from the procedure

Trial details

NCT IDNCT05581524

SponsorI-VASC S.r.l

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Varicose Veins of Lower Limb trials