Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT03267056
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
Sponsor:
Acotec Scientific Co., Ltd
Organization:
Study Overview
Official Title:
Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
Status:
COMPLETED
Status Verified Date:
2020-04
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 registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
Detailed Description:
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
Study Oversight
Has Oversight DMC:
False
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?: