FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite endpoint of all cause mortality, non-fatal Myocardial Infarction, any
Revascularisation and Stroke (MACCE) at 12 months
Secondary outcome
Primary endpoint at 24 and 36 months as well as outcomes of each component of
the primary endpoint at 12 months.
Primary endpoint rates in the subgroup of patients receiving staged or acute
PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of
patients with FFR positive lesion that received optimal medical treatment
Primary endpoint rates in the subgroup of patients receiving acute PCI
treatment for FFR positive lesions in the non-IRA vs the subgroup of patients
receiving staged PCI treatment for FFR positive lesions in the non-IRA
Primary endpoint rates in the subgroup of patients receiving staged PCI
treatment for FFR negative lesions in the non-IRA vs the subgroup of patients
not receiving PCI treatment for FFR negative lesions in the non-IRA at 3 years.
Composite endpoint of Cardiac death, Myocardial Infarction, any
Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net
Adverse Clinical Events)
Background summary
At the moment the general opinion is devided over the way the non culprit
leasions in patients presenting with STEMI should be treated. While the
previous guidelines stead that these leasions should be treated in a second
time ( ie not during the primary intervention) the actual guidelines do not
touch this argument. The reason is that the studies where the previous
guidelines were based are old. Meanwhile small sized randomised trials from EU
region have proven favourable outcomes with NON infarct related artery during
the primary procedure while registers (non randomised trials) from USA still
reccomand the staged treatment. For this reason we have decided to performe a
randomised studie to address this issue incorporating the state of the art
diagnosis and treatment, as well as the new medical therapy and PCI techniques.
Study objective
FFR-guided complete percutaneous revascularisation of all flow-limiting
stenoses in the non-IRA performed within the same procedure as the primary PCI
or within the same hospitalisation will improve clinical outcomes compared to
the staged revascularisation, guided by prove of ischemia or clinical judgment,
as recommended from the guidelines
Study design
Prospective, 1: 2 randomisation
FFR guided revascularisation during primary PCI (1)
Following actual guidelines (2)
Intervention
FFR-guided complete percutaneous revascularisation of all flow-limiting
stenoses in the non-IRA performed within the same procedure as the primary PCI
or within the same hospitalisation will improve clinical outcomes compared to
the staged revascularisation, guided by prove of ischemia or clinical judgment,
as recommended from the guidelines
Study burden and risks
The risks for the patients are the same for regular PCI
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
STEMI patients, between 18-85 years, who will be treated with primary PCI<12h after the onset of symptoms and have at least one stenosis of >50 % in a non IRA on QCA or visual estimation and judged feasible for treatment with PCI by the operator
Exclusion criteria
Left main stem disease, chronic total occlusion of non-IRA, Severe stenosis with TIMI-flow<3 of the non-IRA artery, non-IRA stenosis not amendable for PCI treatment (operators decision) Killip class 3 and 4, Complicated IRA treatment, STEMI due to in-stent stenosis
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 | NL36323.101.11 |