Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330493
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-10
Brief Title:
AcoArt Litos PCB Below-the-knee Global Trial
Sponsor:
Acotec Scientific Co Ltd
Organization:
Acotec Scientific Co Ltd
Study Overview
Official Title:
Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty PTA Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients with Chronic Limb-Threatening Ischemia
Status:
RECRUITING
Status Verified Date:
2024-10
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 objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device FDA cleared PTA Balloon Catheter regarding treatment of obstructions in the infrapopliteal arteries located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint in patients presenting with chronic limb-threatening ischemia CLTIRutherford 4-5
Detailed Description:
None
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?:
None