Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880641
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-05-19
Brief Title:
Use of Shockwave M5 IVL Catheter Intravascular Lithotripsy in Hostile and Calcified Iliac Access
Sponsor:
EndoCore Lab srl
Organization:
EndoCore Lab srl
Study Overview
Official Title:
No-profit Pilot Observational Multicentric Prospective Study on the Use of Shockwave M5 IVL Catheter Intravascular Lithotripsy in Hostile and Calcified Iliac Access to Facilitate Aortic Endovascular Repair SHOCK-ACCESS STUDY
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:
SHOCK-ACCESS
Brief Summary:
The study will evaluate in a controlled setting the efficacy and safety of the intravascular lithotripsy using Shockwave M5 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access
Detailed Description:
This study is designed as no-profit pilot observational multicentric prospective study
All eligible subjects for undergoing intervention with Shockwave M5 Peripheral Intravascular Lithotripsy Catheter 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 M5 Peripheral Intravascular Lithotripsy Catheter 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 M5 Peripheral Intravascular Lithotripsy Catheter 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 M5 Peripheral Intravascular Lithotripsy Catheter 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?:
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