QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions (QUOMODO)

Johannes Gutenberg University (JGU)

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Diagnostic Test: Assessment of angiographic severity of the stenosis

Device: Quantitative flow ratio

Study type

Interventional

Funder types

Other

Identifiers

NCT04808310

2020-15296

Details and patient eligibility

About

The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).

Goals of the study are:

To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS
To investigate whether use of QFR is associated with an improved prognosis.

Full description

The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions.

The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm).

Primary endpoint 1. Angina questionnaire

Secondary endpoints:

Number and % of patients undergoing PCI

Seattle Angina Questionnaire

SAQ Physical limitation scale
SAQ angina stability scale
SAQ angina frequency scale
SAQ quality of life
SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Successfully treated acute coronary syndrome
At least one additional intermediate stenosis (>30% and <90%).
Patient ≥18 years old

Exclusion criteria

Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc).
Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion.
Any contraindication to PCI according to guidelines
An ACS in the period following the index ACS and randomization
TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel
Presence of thrombus in the non-culprit lesion
Participation in another randomized interventional study interfering with the present protocol
Patient unable to give informed consent
Women of child-bearing potential or lactating
Previous coronary artery bypass surgery CABG
Recent (within 30 days) unsuccessful PCI
Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
Left ventricular ejection fraction <30%
Severe chronic obstructive pulmonary disease (COPD)
Severe valvular heart disease
FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure