Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492174
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis ISR - Long Lesion Cohort
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
AGENT IDE A Prospective Randomized 21 Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis ISR
Status:
RECRUITING
Status Verified Date:
2024-09
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:
AGENT IDE
Brief Summary:
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis ISR of a previously treated lesion of up to 36 mm in length by visual estimate in a native coronary artery 20 mm to 40 mm in diameter
Detailed Description:
Please see NCT04647253 for the prospective randomized multi-center single blind trial comparing AGENT DCB to balloon angioplasty POBA
The Long Lesion Cohort is a non-randomized single arm cohort of subjects with ISR of a previously treated lesion 26 mm and 36 mm in length by visual estimate in a native coronary artery 20 mm to 40 mm in diameter
The Long Lesion Cohort is a non-randomized single arm cohort of subjects with ISR of a previously treated lesion 26 mm and 36 mm in length by visual estimate in a native coronary artery 20 mm to 40 mm in diameter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None