NCT05006183

Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Daugavpils Regional Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or ECG changes and/or 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.

Conditions

• Cardiac Ischemia
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	PCI	Percutaneous coronary intervention with Drug-Eluting Stents

Timeline

• Start date: 2019-08-08
• Primary completion: 2023-08-01
• Completion: 2024-09-01
• First posted: 2021-08-16
• Last updated: 2022-04-29

Locations

1 site across 1 country: Latvia