Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT07205068
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Sponsor:
University of Tennessee Graduate School of Medicine
Organization:
Study Overview
Official Title:
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Status:
RECRUITING
Status Verified Date:
2025-08
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 primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
Detailed Description:
This is a prospective randomized/control trial pilot study to compare clinical outcomes of common femoral artery access in patients undergoing TAVR at the University of Tennessee Medical. Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access using the modified Seldinger technique to those utilizing the standard femoral artery access via the modified Seldinger approach without the utilization of intravascular lithotripsy in heavily calcified femoral arteries.
The secondary purposes of this study are to:
1. Determine the clinical outcomes between groups
2. Distinguish extravasation post closure at the end of the procedure
3. Compare the need for open vascular surgery between groups
4. Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups
5. Number of Perclose devices used between groups
6. Compare Bleeding/Hematoma between groups
7. Examine the difference in hospital length of stay between groups
8. Examine renal function post procedure
9. Difference in pain or numbness in the distal extremity between groups
10. Mortality related to complications from vascular closure site between groups
11. Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups
The secondary purposes of this study are to:
1. Determine the clinical outcomes between groups
2. Distinguish extravasation post closure at the end of the procedure
3. Compare the need for open vascular surgery between groups
4. Examine PTA or Stents to the CFA to help hemostasis or local vascular complications between groups
5. Number of Perclose devices used between groups
6. Compare Bleeding/Hematoma between groups
7. Examine the difference in hospital length of stay between groups
8. Examine renal function post procedure
9. Difference in pain or numbness in the distal extremity between groups
10. Mortality related to complications from vascular closure site between groups
11. Conversion to general anesthesia due to additional procedures required to address the CFA access site complications between groups
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Institutional Review Board | OTHER | The University of Tennessee Health Science Center | View |