Vacuum Assisted Sclerotherapy Performed by Catheter

NCT05581524 | Completed

• 1 other identifier: CPS01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Varicose Veins of Lower Limb

Keywords

varicose veins; empty-vein sclerotherapy; chemical ablation; venous catheter

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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

Study Arms (1)

VELEX

EXPERIMENTAL

Treatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy

Device: VASC

Interventions

VASC DEVICE

At day 0 the patient will undergo the VASC treatment procedure with VelexTM device. VelexTM venous catheter is inserted in the introducer and pushed in the desired position under echo guidance. At 7 days, 1, 3 and 6 months after the procedure, the patients will undergo a clinical examination and an echo-color doppler assessment.

Also known as: Velex

VELEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I-VASC S.r.l: lead

Study Sites (2)

IRCCS Policlinico San Donato

Milan, Milan, 20097, Italy

Location

IRCCS San Raffaele

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mario MS Salerno

  I-VASC S.r.l

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 14, 2022
• Study Start: June 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-03

Locations

IT (2)