Varicose Veins of Lower LimbVASCNCT05581524
Vacuum Assisted Sclerotherapy Performed by Catheter
A study testing VASC in people with Varicose Veins of Lower Limb, run by I-VASC S.r.l at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- VASC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Policlinico San Donato
Milan, Milan, 20097
IRCCS San Raffaele
Milan, Milan, 20132
About this study
Official title: V.A.S.C. (Vacuum Assisted Sclerotherapy Performed by Catheter)
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.
Read the detailed description
V.A.S.C. is a multicentric prospective, open label, non-randomized PMCF study of VelexTM venous catheter for patients with varicose veins of lower limb.
The study is designed as a post-market clinical follow-up, aimed at collecting clinical data of VelexTM venous catheter used according to the indication of use within the scope of the CE mark.
The study will enrol a maximum number of 36 patients at the participating sites. All the subjects will be evaluated at immediate post-procedure, 7 days, 1, 3 and 6 months after the procedure.
The eligibility criteria are compliant with the indication of use within the scope of the CE mark.
Several preclinical tests were carried out for assessing the safety of VelexTM venous catheter: in vitro tests, biocompatibility and preclinical-vivo test.
In-vitro test All the in-vitro tests were performed on samples at time zero and after aging, in order to simulate conditions of transport and storage of the device Biocompatibility The biocompatibility assessment included the overall evaluation of the device, including the manufacturing materials of the various components, the manufacturing processes, the clinical use of the device, including the expected anatomical location, and the frequency and duration of exposure.
According to ISO 10993-1, VelexTM venous catheter is classified as an external communication device with limited contact duration (≤24 hours), with contact with circulating blood. According to this category, dedicated tests were performed to provide data regarding specific biological effects:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Pyrogenicity
- Acute systemic toxicity
- Hemocompatibility In all the biocompatibility test, the samples met the acceptance criteria. On the basis of biocompatibility tests carried out, VelexTM venous catheter device complies with the biocompatibility requirements according to ISO 10993-1: 2018.
Preclinical in-vivo test A preclinical in-vivo test was performed on ovine animal model in order to evaluate the safety of the device in conditions consistent with the clinical use and to verify the echogenicity of the device under ultrasound. Sclerotherapy procedure was simulated in jugular vein of adult sheep.
Most of the procedures (9/15) were successfully completed. Among the remaining 6 cases, 4 cases resulted in an incomplete procedure due to out of procedure (not conform to the IFU); in 2 procedures with the same catheter the user encountered resistance to catheter movement, therefore the catheter was retrieved but no damage to the device or to the vein was detected.
In order to simulate the dynamic method, the catheter with inflated balloons was repeatedly moved along the vessel without any issue.
By means of diagnostic imaging, the position of the catheter was checked, as well as balloons inflation and deflation, confirming the safety of the mechanism of action of the device. Hereafter, the device features positively assessed by these tests are listed:
- Safe compatibility with Seldinger technique;
- Good pushability/trackability;
- Excellent echogenicity;
- Safe inflation/deflation of balloons;
- Safe isolation of vein segment;
- Safe fluid injection;
- Safe displacement of the catheter;
- Safe fluid aspiration;
- Safe retrieval of the catheter;
- Safe synchronism mechanism (handle). In addition, it is remarkable that no damages to the vein nor to catheter were observed. Damages to catheter were observed only when out of procedures occurred.
The in-vivo test confirmed the results of the in-vitro test in term of safety and ease of use of VelexTM venous catheter.
Evaluation of clinical data that are relevant to the proposed clinical investigation At the moment, the clinical evaluation of VelexTM catheter is based on literature data regarding the use of catheters for sclerotherapy.
Sclerotherapy is a well established treatment for small varicose vein but there are some limitations due to lack of standardization of the technique and the anatomical recurrence rate remains higher than the other endovenous options. The use of long catheters for sclerotherapy has been described since 1997. Through the use of catheters with occlusion balloons, the sclerosing agent can be maintained in contact with the venous inner wall for the period necessary to stimulate an endothelial response; furthermore, the occlusion balloon decreases the probability of damage to the structures of the deep venous system due to the migration of the sclerosant.
The major challenge that remains with any type of catheter is how to standardize the dose of therapeutic agent to be used during the procedure and to be able to distribute it evenly along the vascular wall.
Clinical data from scientific literature show that sclerotherapy with a catheter under echo guidance is safe and leads to clinical benefit for patients. The use of VelexTM is consistent with the current medical knowledge in the treatment of varicose veins. Indeed, VelexTM is a catheter with features that allow to control the concentration of sclerosant agent in an isolated venous segment emptied from blood and to keep it in place for the time deemed necessary.
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.
The device allows to isolate the vein section to be treated, to release the sclerosant agent in the lesion to be treated through the medication administration holes and to recapture the injected liquid, preventing undesired side effects.
It is composed by the following parts:
- Three-balloon catheter: main body and invasive part of the device;
- Handle: it manages the balloon and the medication infusion;
- Syringe preparation lines: silicone tubes to be connected to the handle in order to fill the syringes;
- Depth marker: sliders (C-shape rings) connected by a spacer. VelexTM venous catheter is intended to temporary inhibit blood flow in isolated sections of the peripheral veins of the lower limbs to infuse therapeutic agents (foam excluded) prescribed by physician for sclerotherapy.
The intended purpose of VelexTM venous catheter in the PMCF study coincides with the indication of use within the scope of the CE mark.
VelexTM venous catheter is intended for patients affected by lower limb CVD. The suitability of the patient is to be verified case by case by the specialized physician, by means of proper physical examination and evaluation of superficial and deep venous system by means of color Doppler echocardiography.
VelexTM venous catheter should be used by physicians having a deep knowledge of:
- vascular anatomy
- venous system pathology
- endovascular peripheral procedures and endovascular methods
- Seldinger technique or techniques for surgical isolation of a superficial vein
- diagnostic methods, especially peripheral echo color Doppler echocardiography of deep and superficial venous system and angiography.
VelexTM venous catheter shall be inserted in a vein of the lower limb by means of direct phlebotomy or Seldinger technique with 7 Fr introducer, and placed in the desired position under echo guidance.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- VASC
- Keywords
- varicose veins, empty-vein sclerotherapy, chemical ablation, venous catheter
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASCDevice
Also called Velex
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.
| Study group | Role | What they receive |
|---|---|---|
| VELEX | Experimental | Treatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy Receives: Device: VASC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 7 days from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start7 Jun 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-VASC S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario MS Salerno, Study chair, I-VASC S.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581524
- Sponsor's protocol ID
- CPS01
- Acronym
- VASC
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V.A.S.C. (Vacuum Assisted Sclerotherapy Performed by Catheter)
- ClinicalTrials.gov ID
- NCT05581524
- Acronym / sponsor ID
- VASC / CPS01
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- varicose veins, empty-vein sclerotherapy, chemical ablation, venous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- I-VASC S.r.lIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
V.A.S.C. is a multicentric prospective, open label, non-randomized PMCF study of VelexTM venous catheter for patients with varicose veins of lower limb.
The study is designed as a post-market clinical follow-up, aimed at collecting clinical data of VelexTM venous catheter used according to the indication of use within the scope of the CE mark.
The study will enrol a maximum number of 36 patients at the participating sites. All the subjects will be evaluated at immediate post-procedure, 7 days, 1, 3 and 6 months after the procedure.
The eligibility criteria are compliant with the indication of use within the scope of the CE mark.
Several preclinical tests were carried out for assessing the safety of VelexTM venous catheter: in vitro tests, biocompatibility and preclinical-vivo test.
In-vitro test All the in-vitro tests were performed on samples at time zero and after aging, in order to simulate conditions of transport and storage of the device Biocompatibility The biocompatibility assessment included the overall evaluation of the device, including the manufacturing materials of the various components, the manufacturing processes, the clinical use of the device, including the expected anatomical location, and the frequency and duration of exposure.
According to ISO 10993-1, VelexTM venous catheter is classified as an external communication device with limited contact duration (≤24 hours), with contact with circulating blood. According to this category, dedicated tests were performed to provide data regarding specific biological effects:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Pyrogenicity
- Acute systemic toxicity
- Hemocompatibility In all the biocompatibility test, the samples met the acceptance criteria. On the basis of biocompatibility tests carried out, VelexTM venous catheter device complies with the biocompatibility requirements according to ISO 10993-1: 2018.
Preclinical in-vivo test A preclinical in-vivo test was performed on ovine animal model in order to evaluate the safety of the device in conditions consistent with the clinical use and to verify the echogenicity of the device under ultrasound. Sclerotherapy procedure was simulated in jugular vein of adult sheep.
Most of the procedures (9/15) were successfully completed. Among the remaining 6 cases, 4 cases resulted in an incomplete procedure due to out of procedure (not conform to the IFU); in 2 procedures with the same catheter the user encountered resistance to catheter movement, therefore the catheter was retrieved but no damage to the device or to the vein was detected.
In order to simulate the dynamic method, the catheter with inflated balloons was repeatedly moved along the vessel without any issue.
By means of diagnostic imaging, the position of the catheter was checked, as well as balloons inflation and deflation, confirming the safety of the mechanism of action of the device. Hereafter, the device features positively assessed by these tests are listed:
- Safe compatibility with Seldinger technique;
- Good pushability/trackability;
- Excellent echogenicity;
- Safe inflation/deflation of balloons;
- Safe isolation of vein segment;
- Safe fluid injection;
- Safe displacement of the catheter;
- Safe fluid aspiration;
- Safe retrieval of the catheter;
- Safe synchronism mechanism (handle). In addition, it is remarkable that no damages to the vein nor to catheter were observed. Damages to catheter were observed only when out of procedures occurred.
The in-vivo test confirmed the results of the in-vitro test in term of safety and ease of use of VelexTM venous catheter.
Evaluation of clinical data that are relevant to the proposed clinical investigation At the moment, the clinical evaluation of VelexTM catheter is based on literature data regarding the use of catheters for sclerotherapy.
Sclerotherapy is a well established treatment for small varicose vein but there are some limitations due to lack of standardization of the technique and the anatomical recurrence rate remains higher than the other endovenous options. The use of long catheters for sclerotherapy has been described since 1997. Through the use of catheters with occlusion balloons, the sclerosing agent can be maintained in contact with the venous inner wall for the period necessary to stimulate an endothelial response; furthermore, the occlusion balloon decreases the probability of damage to the structures of the deep venous system due to the migration of the sclerosant.
The major challenge that remains with any type of catheter is how to standardize the dose of therapeutic agent to be used during the procedure and to be able to distribute it evenly along the vascular wall.
Clinical data from scientific literature show that sclerotherapy with a catheter under echo guidance is safe and leads to clinical benefit for patients. The use of VelexTM is consistent with the current medical knowledge in the treatment of varicose veins. Indeed, VelexTM is a catheter with features that allow to control the concentration of sclerosant agent in an isolated venous segment emptied from blood and to keep it in place for the time deemed necessary.
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.
The device allows to isolate the vein section to be treated, to release the sclerosant agent in the lesion to be treated through the medication administration holes and to recapture the injected liquid, preventing undesired side effects.
It is composed by the following parts:
- Three-balloon catheter: main body and invasive part of the device;
- Handle: it manages the balloon and the medication infusion;
- Syringe preparation lines: silicone tubes to be connected to the handle in order to fill the syringes;
- Depth marker: sliders (C-shape rings) connected by a spacer. VelexTM venous catheter is intended to temporary inhibit blood flow in isolated sections of the peripheral veins of the lower limbs to infuse therapeutic agents (foam excluded) prescribed by physician for sclerotherapy.
The intended purpose of VelexTM venous catheter in the PMCF study coincides with the indication of use within the scope of the CE mark.
VelexTM venous catheter is intended for patients affected by lower limb CVD. The suitability of the patient is to be verified case by case by the specialized physician, by means of proper physical examination and evaluation of superficial and deep venous system by means of color Doppler echocardiography.
VelexTM venous catheter should be used by physicians having a deep knowledge of:
- vascular anatomy
- venous system pathology
- endovascular peripheral procedures and endovascular methods
- Seldinger technique or techniques for surgical isolation of a superficial vein
- diagnostic methods, especially peripheral echo color Doppler echocardiography of deep and superficial venous system and angiography.
VelexTM venous catheter shall be inserted in a vein of the lower limb by means of direct phlebotomy or Seldinger technique with 7 Fr introducer, and placed in the desired position under echo guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study
| Arm | Type | Receives |
|---|---|---|
| VELEX | Experimental | Device: VASCTreatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VASCAlso: VelexAt 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. | Device | VELEX |
Primary outcome
Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use
Time frame: 3 months
After 3 months, patients will be asked to fill a questionnaire of quality of life.
Pain level
Time frame: At day 0 (day of procedure)
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
Pain level
Time frame: 7 days from the procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario MS Salerno study chair
I-VASC S.r.l
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VASC in people with Varicose Veins of Lower Limb, run by I-VASC S.r.l at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.