Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05581524
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-10-05
Brief Title:
Vacuum Assisted Sclerotherapy Performed by Catheter
Sponsor:
I-VASC Srl
Organization:
I-VASC Srl
Study Overview
Official Title:
VASC Vacuum Assisted Sclerotherapy Performed by Catheter
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VASC
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
VASC 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
VASC 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:
VASC 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 915 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 pushabilitytrackability
Excellent echogenicity
Safe inflationdeflation 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
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 915 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 pushabilitytrackability
Excellent echogenicity
Safe inflationdeflation 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None