Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 5:17 PM
Study NCT ID:
NCT04525794
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRight DCB First-in-Human Study
Sponsor:
Biotronik CRC Inc.
Organization:
Study Overview
Official Title:
BIOTRONIK- First-in-Human Assessment of the Safety and Clinical Performance of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Treatment of Subjects With de Novo Lesions in the Superficial Femoral and Proximal Popliteal Artery (BRight First Study)
Status:
COMPLETED
Status Verified Date:
2024-05
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 aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.
The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: