Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 5:46 PM
Study NCT ID:
NCT02941224
Status:
None
Last Update Posted:
2019-11-20 00:00:00
First Post:
2016-10-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries
Sponsor:
None
Organization:
Study Overview
Official Title:
SELUTION™ Sirolimus Coated PTA Balloon Catheter Prospective, Controlled, Multi-Center, Open, Single-Arm Clinical Investigation for the Treatment of Patients With Femoropopliteal Artery Lesions With a Novel Drug Coated Balloon
Status:
None
Status Verified Date:
2019-11
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 objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries.
The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.
The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: