Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05755412
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-02-22
Brief Title:
Shockwave S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses andor Occlusions in CLTI Patients LEGACY
Sponsor:
EndoCore Lab srl
Organization:
EndoCore Lab srl
Study Overview
Official Title:
Observational Prospective Single-arm Multicentric Study of Shockwave S4 Catheter IVL Intravascular Lithotripsy Balloon for the Treatment of Infrapopliteal Calcified Stenoses andor Occlusions in Patients With Critical Limb Ischaemia
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
LEGACY
Brief Summary:
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter for the treatment of de novo re-stenosis or re-occlusivecalcified chronic total occlusion CTOs lesions in patients with Critical Limb Threatening Ischemia CLTI
Detailed Description:
The present study is designed as a multicentre prospective single-arm observational study
All eligible subjects for undergoing intervention with Shockwave S4 catheter Peripheral Intravascular Lithotripsy IVL at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data Once patients are enrolled their demographics medical history disease-relevant conditions treatment details and outcomes will be collected for up to 12 months from the procedure
The study will collect information about the medical care patients receive during their planned procedure No additional testing or procedures will be done
The procedure with Shockwave S4 catheter Peripheral Intravascular Lithotripsy IVL will be performed as per the current instructions for use
After discharge all patients will attend clinic visits at 30 days 14 days 6 months 30 days12 months 30 days
All eligible subjects for undergoing intervention with Shockwave S4 catheter Peripheral Intravascular Lithotripsy IVL at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating
Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data Once patients are enrolled their demographics medical history disease-relevant conditions treatment details and outcomes will be collected for up to 12 months from the procedure
The study will collect information about the medical care patients receive during their planned procedure No additional testing or procedures will be done
The procedure with Shockwave S4 catheter Peripheral Intravascular Lithotripsy IVL will be performed as per the current instructions for use
After discharge all patients will attend clinic visits at 30 days 14 days 6 months 30 days12 months 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None