Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340763
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-12
Brief Title:
JETi Hong Kong Post Market Study PMS
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The JETi Hong Kong PMS is a prospective single-arm multicenter study to collect real-world data on the safety performance and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong Subjects participating in this study will be followed for up to 30 days after the JETi procedure
Detailed Description:
The JETi System is a hydro-mechanical aspiration system manufactured by Abbott Medical consisting of a catheter pump set and accessories The system is intended to removeaspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to subselectively infusedeliver diagnostics or therapeutics with or without vessel occlusion
This study will collect data on how the JETi System performs in the treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral arterial or venous thrombosis of the lower extremity Each participating investigator will determine and implement the best treatment strategy for their patients based on the clinical situation and local physician practices All investigators involved in the conduct of the study will be qualified by education training and experience to perform their tasks
This study will collect data on how the JETi System performs in the treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral arterial or venous thrombosis of the lower extremity Each participating investigator will determine and implement the best treatment strategy for their patients based on the clinical situation and local physician practices All investigators involved in the conduct of the study will be qualified by education training and experience to perform their tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRD_1058 | OTHER | Abbott | None |