Determine the range of post-PCI iFR and the rate of significant residual ischemia defined as iFR
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of residual ischemia defined as iFR <0.90 after operator-assessed
angiographically successful PCI (residual diameter stenosis <50% in any treated
lesion in the target vessel)
Secondary outcome
Secondary clinical endpoints:
1. Composite of cardiac death, target vessel myocardial infarction,
ischemia-driven target vessel revascularization or recurrent ischemia at one
year (definition below)
2. Target vessel failure defined as cardiac death, target vessel myocardial
infarction, ischemia-driven target vessel revascularization
3. Quality of life (assessed by the Seattle Angina Questionnaire) at baseline,
30-days, 6 months and 1year
4. All-cause and cardiac mortality at one year
5. Target vessel Myocardial infarction at one year
6. Ischemia-driven target vessel revascularization at one year
7. Recurrent ischemia at one-year
Secondary physiology endpoints:
8. Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual
interpretation
9. Proportion of cases in which the iFR would become non-significant if a focal
stenosis demonstrated by iFR pullback were treated with PCI
10. Differentiation of the cause for impaired iFR (categorized as stent
related, distant focal stenosis, or diffuse atherosclerosis)
11. Predictors of delta iFR before and after PCI
Background summary
Numerous studies of coronary stenting over the past decade have consistently
demonstrated that recurrent episodes of angina within the first year post PCI
are common, occurring in approximately 20% of patients. This may lead to a
substantial increase in repeat invasive procedures and associated health care
costs.
Physiologic assessment of coronary stenoses prior to percutaneous coronary
intervention (PCI) is superior to coronary angiography alone for lesion
evaluation, reducing overall major cardiac events as well as cost. However,
data on post PCI physiology is scarce and thus rarely used in clinical
practice. Limited clinical data on post PCI Fractional Flow Reserve (FFR) and
instantaneous wave-free ratio (iFR) indicate that a substantial number of
patients (up to 20%) have impaired coronary physiology at the completion of the
procedure despite an angiographically successful PCI. It is not known whether
an abnormal post-PCI FFR or iFR is predictive of recurrent angina and whether
the routine use of physiological indices of coronary function can predict
future cardiovascular events.
iFR safely and accurately quantifies stenosis severity in a wide range of
lesions and may be helpful in assessing post PCI physiology. Compared with FFR,
it allows rapid assessment of the lesion without induction of maximal hyperemia
with adenosine. iFR pullback has the potential additional advantage of
interrogating the entire coronary artery to identify culprit lesions with
significant pressures gradients.
Study objective
Determine the range of post-PCI iFR and the rate of significant residual
ischemia defined as iFR <0.90 following operator-assessed angiographically
successful PCI
Study design
DEFINE-PCI is a multi-center, prospective, observational study in up to 25
centers in USA and internationally. Consented subjects with CAD who undergo
physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are
eligible for participation. After successful PCI to all culprit lesions based
on angiographic assessment of the treating physician, a blinded post-PCI iFR
and iFR pullback will be performed. The proportion of patients with impaired
post-PCI iFR will be assessed, and the number of patients in whom ischemia
could theoretically be normalized with further PCI determined. Additionally,
the association between the post-PCI iFR results and cardiovascular events and
clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months,
including administration of quality of life questionnaires.
Study burden and risks
As part of this study patients will be undergoing the following assessments in
addition to the normal treatment:
-an additional IFR measurement of the treated coronary arteries after PCI.
-4-8h after PCI a single blood sample will be drawn for the determination of
cardiac biomarkers.
-after 1, 6 and 12 months, the patient will be contacted by telephone to assess
events and medication.
-each visit a questionnaire will be completed/ filled in by the patient.
The duration of the procedure is extended by the additional IFR measurement.
The extra time may vary from 5 minutes to half an hour, depending on the number
of vessels that is measured.
Excelsiorlaan 41
Zaventem 1930
NL
Excelsiorlaan 41
Zaventem 1930
NL
Listed location countries
Age
Inclusion criteria
1.Subject must be > 18 years old
2.Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (unstable angina or biomarker positive)
3.Single vessel CAD with at least 2 separate lesions (*10 mm apart) of *40% stenosis or a single long lesion of *20mm OR multi-vessel CAD, defined as at least 2 vessels with *40% stenosis
4.Pre-PCI iFR performed in all vessels intended for PCI
5.Pre-PCI iFR of <0.90 of at least 1 stenosis
6.Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.
Exclusion criteria
1.Pregnant or planning to become pregnant for the duration of the study
2.Acute STEMI within the past 7 days
3.Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
4.Ionotropic or temporary pacing requirement
5.Sustained ventricular arrhythmias
6.Prior CABG
7.Known ejection fraction *30%
8.Chronic Total Occlusion (CTO)
9.Known severe mitral or aortic stenosis.
10.Any known medical comorbidity resulting in life expectancy < 12 months.
11.Participation in any investigational study that has not yet reached its primary endpoint.
12.Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
13.TIMI flow <3 at baseline
14.Intra-coronary thrombus on baseline angiography
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03084367 |
| CCMO | NL61437.029.17 |