NCT04808310CompletedPhase 4
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 17 Mar 2021
- Start date
- 1 Oct 2020
- Primary completion date
- 1 Apr 2023
- Lead sponsor
- Johannes Gutenberg University Mainz
- Diseases
- Coronary artery disease
- NCT number
- NCT04808310
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 200
- From 1 Oct 2020 to the primary completion date, 1 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Previous coronary artery bypass surgery CABG
Other illness
- TIMI (Thrombolysis in Myocardial Infarction) flow grade \< 3 in the culprit vessel
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- Severe chronic obstructive pulmonary disease (COPD)
- Severe valvular heart disease
Lab values
- Left ventricular ejection fraction \<30%
Other
- 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
- 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
- Recent (within 30 days) unsuccessful PCI
- FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure
Who the study is looking for
- Successfully treated acute coronary syndrome
- At least one additional intermediate stenosis (\>30% and \<90%).
- Patient ≥18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of Cardiology, Cardiology I, university hospital Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.