Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559332
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Coronary Artery Disease Assessment Strategies in TAVI Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAT
Brief Summary:
Coronary artery disease CAD and aortic stenosis frequently coincide Before valve intervention invasive coronary angiography is routinely performed to assess coronary status
As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms the benefitrisk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation TAVI is unclear
The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 1 and 3 years primary objective and patient reported outcome measures secondary objective
As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms the benefitrisk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation TAVI is unclear
The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 1 and 3 years primary objective and patient reported outcome measures secondary objective
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None