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

Daugavpils Regional Hospital

Status: Enrolling

Conditions: Acute Coronary Syndrome; Cardiac Ischemia

Treatments: Procedure: PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT05006183

SP0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• willing to give informed consent
• hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries
• adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
• sinus rhythm

Exclusion criteria

• inability to give consent;
• younger than 18 years of age
• atrial fibrillation rhythm at the time of inclusion
• with significant valve disease
• in cardiogenic shock
• with reduced kidney function - eGFR < 30 (mL/min/1.73m2);
• with congenital heart defects
• with acute pulmonary artery embolism;
• with isolated left main ostial stenosis;
• on active oncologic treatment or toxic cardiomyopathy;
• revascularization by PCI is not possible due to other comorbidities or patient denial of treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

iFR-guided

Experimental group

Description:

One-stage, virtually planned, iFR-guided and optimized PCI.

Treatment:

Procedure: PCI

Angiography-guided

Active Comparator group

Description:

Standard practice staged angiography-guided PCI

Treatment:

Procedure: PCI