Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT03943160
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2019-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
Status:
COMPLETED
Status Verified Date:
2023-07
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:
REACH PVI
Brief Summary:
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
Detailed Description:
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: