Status:
COMPLETED
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed 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-proto...
Eligibility Criteria
Inclusion
- Successfully treated acute coronary syndrome
- At least one additional intermediate stenosis (\>30% and \<90%).
- Patient ≥18 years old
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04808310
Start Date
October 1 2020
End Date
April 17 2024
Last Update
October 8 2024
Active Locations (1)
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1
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, Germany, 55131