2.1 Primary ObjectiveTo determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of MACE.2.2 Secondary ObjectivesTo describe the test/retest repeatability of combined FFR and CFR measurements.To explore…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
• 24-month rate of major adverse cardiac events:
o all-cause death
o documented myocardial infarction
o unplanned, urgent revascularization (not cross-over revascularization)
o elective revascularization (both non-urgent and repeat procedures)
Secondary outcome
Secondary endpoints
• Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
at 6, 12, 18, and 24 months (then 5 and potentially also 10 years depending on
resources)
• Number of anti-anginal medications at the same time points as CCS angina class
• Cerebrovascular events at any time
• Bland-Altman bias, limits of agreement, and reproducibility coefficient for
repeated physiology measurements
• Procedure time from anticoagulation to completion of physiologic measurements
• Number of tracings excluded by core physiology lab due to noise, artifact, or
loss of signal
Background summary
Optimal selection of lesions for percutaneous coronary intervention (PCI)
remains an important challenge, given both the cost and invasive nature of the
procedure. Prior randomized trials [17531660] [19144937] [22924638] have
demonstrated that mainly stable patients with atherosclerotic coronary artery
disease (CAD) experience superior outcomes when fractional flow reserve (FFR)
guides PCI instead of anatomic appearance. However, FAME 2 indicates that
approximately 80% of patients experience no adverse events over 1 year despite
a reduced FFR [22924638]. Therefore, a clear opportunity exists for further
refinement of lesion selection for PCI.
Conceptually, pressure-based FFR alone cannot fully describe the clinical
physiology of the coronary arteries [16940193]. Instead, the three variables of
pressure, flow, and resistance together are required, of which only two are
simultaneously independent. Hence, it remains unproven if physiologic measures
of stenosis severity in addition to FFR can refine selection of lesions for PCI
or offer independent prognostic value.
Study objective
2.1 Primary Objective
To determine the prognostic value of combined FFR and CFR measurements to
predict the 24-month rate of MACE.
2.2 Secondary Objectives
To describe the test/retest repeatability of combined FFR and CFR measurements.
To explore individual components of MACE, alternative MACE groupings, and
angina burden.
To determine the rate of MACE and angina burden during extended follow-up (up
to 5 years depending on study resources).
To document the procedural effort and success rate for combined pressure and
Doppler flow measurements.
2.3 Exploratory Objectives
For each alternative physiologic variable, the prognostic value, test/retest
repeatability, and angina burden will be computed in an analogous manner to CFR
above.
Study design
Prospective, observational, non-randomized, multicenter study
Intervention
Based on the average FFR and CFR measurements, PCI will be performed
immediately or deferred as follows:
• FFR >0.8 = defer
• FFR <=0.8
o CFR <2.0 = immediate PCI
o CFR >=2.0 = defer
Study burden and risks
The risks associated with participation in the study are equivalent of those
associated with standard FFR-guidance of
treatment. De patien burden consists of telephone contact at 6, 12, 18, 24
months and 5 years, and if funding allows at 10 years.
Fannin St., 6431
Houston TX 77030
US
Fannin St., 6431
Houston TX 77030
US
Listed location countries
Age
Inclusion criteria
3.1 Inclusion Criteria, 3.1.1 Age >= 18 years., 3.1.2 Eligible for PCI based on
local practice standards during the current procedure (PCI cannot be staged).,
3.1.3 At least one epicardial stenosis of >=50% diameter (by visual or
quantitative assessment) and meeting the following criteria as determined by
the operator based on either a prior or the current diagnostic angiogram:
• <100% diameter (not a chronic, total occlusion);
• in a native coronary artery (including side branches but excludes bypass
grafts);
• of >=2.5mm reference diameter (near the level of the stenosis);
• and supplies sufficiently viable myocardium (exclude regions of known, prior,
transmural myocardial infarction)., 3.1.4 Ability to understand and the
willingness to sign a written informed consent.
Exclusion criteria
Anatomic exclusions:, 3.2.1 Prior CABG., 3.2.2 Preferred treatment strategy for
revascularization would be CABG based on local practice standards., 3.2.3 Left
main coronary artery disease requiring revascularization., 3.2.4 Extremely
tortuous or calcified coronary arteries precluding intracoronary physiologic
measurements. Operators may also exclude subtotal or similar high-grade
lesions, which in their judgment may be threatened by ComboWire placement.,
3.2.5 Known severe LV hypertrophy (septal wall thickness at echocardiography of
>13 mm)., Clinical exclusions:
3.2.6 Inability to receive intravenous adenosine (for example, severe reactive
airway disease, marked hypotension, or high-grade AV block without pacemaker).,
3.2.7 Recent (within 3 weeks prior to cardiac catheterization) ST-segment
elevation myocardial infarction (STEMI) in any arterial distribution (not
specifically target lesion)., 3.2.8 Culprit lesions (based on clinical judgment
of the operator) for either STEMI or non-STEMI cannot be included., 3.2.9
Severe cardiomyopathy (LV ejection fraction <30%)., 3.2.10 Planned need for
cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or
septal myomectomy)., General exclusions:
3.2.11 A life expectancy of less than 2 years., 3.2.12 Inability to sign an
informed consent, due to any mental condition that renders the subject unable
to understand the nature, scope, and possible consequences of the trial or due
to mental retardation or language barrier., 3.2.13 Potential for non-compliance
towards the requirements for follow-up visits., 3.2.14 Participation or planned
participation in another cardiovascular clinical trial before completing the 24
month follow-up.
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 |
|---|---|
| CCMO | NL48375.018.14 |