Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05006183
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2021-08-02
Brief Title:
Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome
Sponsor:
Daugavpils Regional Hospital
Organization:
Daugavpils Regional Hospital
Study Overview
Official Title:
Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio iFR in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
iStrategy
Brief Summary:
A single-center prospective randomized open-label blinded end-point clinical trial of instantaneous wave-free ratio iFR guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome ACS patients
Detailed Description:
The all-comers study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50 and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction TIMI flow 2 and willing to sign a patient informed consent ACS diagnosis established by angina pectoris symptoms andor ECG changes andor hs-troponin I levels The use of drug-eluting stents is mandatory in both treatment groups In the intervention strategy group patients are treated by the iFR-guided percutaneous coronary intervention PCI in one stage In the control group patients are treated in accordance with the standard practice of angiography-guided staged approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None