Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358508
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-05
Brief Title:
Sapphire 3 CTO Study
Sponsor:
OrbusNeich
Organization:
OrbusNeich
Study Overview
Official Title:
Sapphire 3 - A Prospective Open Label Multi-center Single Arm Observational Study Designed to Evaluate the Acute Safety and Device Performance of the Sapphire 3 085-125 mm Coronary Dilatation Catheter in Predilatation of Chronic Total Occlusion CTO Lesions During Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
A prospective open label multi-center single arm observational study designed to evaluate the acute safety and device performance of the Sapphire 3 085 10 and 125mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion CTO lesions during percutaneous coronary intervention
One hundred seventy 170 subjects will be enrolled with a target of one hundred fifty-three 153 evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 085 10 and 125mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion which is defined as 24-hours post-procedure or hospital discharge whichever comes first
One hundred seventy 170 subjects will be enrolled with a target of one hundred fifty-three 153 evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 085 10 and 125mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion which is defined as 24-hours post-procedure or hospital discharge whichever comes first
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None