Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05669222
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2022-12-18
Brief Title:
The FAVOR V AMI Trial
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
Functional and Angiography-Derived Strain Guided Multi-VesselLesion Revascularization Strategy in Patients With Acute ST-Segment Elevation Myocardial Infarction FAVOR V AMI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The FAVOR V AMI study is a prospective multicenter blinded randomized sham-controlled trial comparing the long-term clinical outcomes of the Functional and Angiography-derived Strain inTegration FAST technique next-generation quantitative flow ratio μQFR and radial wall strain RWS guided percutaneous coronary intervention PCI strategy with standard treatment strategy in patients with ST-segment elevation myocardial infarction STEMI and multivessel coronary disease MVD
Detailed Description:
The FAVOR V AMI study is a prospective multicenter blinded randomized sham-controlled trial comparing the long-term clinical outcome of the two PCI strategies the FAST guided strategy test group versus standard treatment strategy control group in a high-risk population with STEMI and MVD who underwent successful primary PCI of the infarct-related artery The primary endpoint is major adverse cardiac events MACE defined as a composite of all-cause death myocardial infarction MI or ischemia-driven revascularization when the last patient reaches 6-month follow-up The major secondary endpoint is cardiovascular death and MI when at least 395 total events have accrued The study hypothesis is the FAST μQFRRWS guided PCI strategy is superior to a standard treatment strategy by the primary and major secondary endpoint
For the patients randomized to μQFRRWS group μQFR will be measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed percentage diameter stenosis DS 50 and 90 with reference vessel diameter RVD 25 mm If μQFR 080 or RWS 13 PCI will be performed if μQFR 080 and RWS 13 the procedure will deferral if DS 90 PCI should be performed without the need of μQFR or RWS For all patients undergoing PCI post-PCI μQFR measurement is recommended if μQFR 090 if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered if the reason is not obvious intravascular imaging should be considered For the patients randomized to standard treatment group PCI should be performed of all non-culprit lesions with visual DS 70 in all non-infarct related arteries with RVD 25 mm for a non-culprit lesion with visually DS 50-70 PCI can be performed if fractional flow reserve FFR 080 or instantaneous wave-free ratio iFR 089 All patients will be followed by either telephone or clinic visit at 1 month 6 months1 year 2 years 3 years 4 years and 5 years
The sample size will be about 5000 using an event-driven sample calculation An adaptive design will be implemented for sample size re-estimation when 90 of patients have been enrolled All principal analyses will take place in the intention-to-treat ITT population The primary and major secondary endpoints will be analyzed in prespecified subgroups including age 65 vs 65 sex men vs women diabetes yes vs no time from symptom onset to primary PCI vs median planned number of NCLs for PCI in the control arm 01 vs 2 vs 3 infarct related artery LMLAD vs others untreated CTOs with RVD 25 mm in non-infarct related artery yes vs no timing of elective PCI same hospitalization as the emergency PCI vs during an elective readmission P2Y12 inhibitor therapy Clopidogrel vs Ticagrelor treatment of any non-infarct lesion with DS 90 prior to randomization yes vs no LVEF echo post primary PCI prior to randomization 40 vs 40 Killip Class I vs II lesion location of non-culprit lesion LMLAD vs others diseased vessels two-vessel disease vs LMthree-vessel disease moderate or severe calcification in any NCL yes vs no bifurcation lesion with planned main vessel and SB treatment in any NCL yes vs no intravascular guidance during the randomized procedure yes vs no μQFR grayzone μQFR 075 vs 075-085 vs 085 by core laboratory μQFR-based functional SYNTAX score FSSQFR low tertile vs mid tertile vs high tertile by core laboratory post-PCI μQFR 090 vs 090 by core laboratory angiography-derived IMR 25 mmHgscm vs 25 mmHgscm by core laboratory residual physiology pattern PPG diffuse vs local by core laboratory μQFR-based residual functional SYNTAX score rFSSQFR 0 vs 1 by core laboratory learning experience of μQFRRWS first half vs second half of enrolled cases in each center
For the patients randomized to μQFRRWS group μQFR will be measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed percentage diameter stenosis DS 50 and 90 with reference vessel diameter RVD 25 mm If μQFR 080 or RWS 13 PCI will be performed if μQFR 080 and RWS 13 the procedure will deferral if DS 90 PCI should be performed without the need of μQFR or RWS For all patients undergoing PCI post-PCI μQFR measurement is recommended if μQFR 090 if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered if the reason is not obvious intravascular imaging should be considered For the patients randomized to standard treatment group PCI should be performed of all non-culprit lesions with visual DS 70 in all non-infarct related arteries with RVD 25 mm for a non-culprit lesion with visually DS 50-70 PCI can be performed if fractional flow reserve FFR 080 or instantaneous wave-free ratio iFR 089 All patients will be followed by either telephone or clinic visit at 1 month 6 months1 year 2 years 3 years 4 years and 5 years
The sample size will be about 5000 using an event-driven sample calculation An adaptive design will be implemented for sample size re-estimation when 90 of patients have been enrolled All principal analyses will take place in the intention-to-treat ITT population The primary and major secondary endpoints will be analyzed in prespecified subgroups including age 65 vs 65 sex men vs women diabetes yes vs no time from symptom onset to primary PCI vs median planned number of NCLs for PCI in the control arm 01 vs 2 vs 3 infarct related artery LMLAD vs others untreated CTOs with RVD 25 mm in non-infarct related artery yes vs no timing of elective PCI same hospitalization as the emergency PCI vs during an elective readmission P2Y12 inhibitor therapy Clopidogrel vs Ticagrelor treatment of any non-infarct lesion with DS 90 prior to randomization yes vs no LVEF echo post primary PCI prior to randomization 40 vs 40 Killip Class I vs II lesion location of non-culprit lesion LMLAD vs others diseased vessels two-vessel disease vs LMthree-vessel disease moderate or severe calcification in any NCL yes vs no bifurcation lesion with planned main vessel and SB treatment in any NCL yes vs no intravascular guidance during the randomized procedure yes vs no μQFR grayzone μQFR 075 vs 075-085 vs 085 by core laboratory μQFR-based functional SYNTAX score FSSQFR low tertile vs mid tertile vs high tertile by core laboratory post-PCI μQFR 090 vs 090 by core laboratory angiography-derived IMR 25 mmHgscm vs 25 mmHgscm by core laboratory residual physiology pattern PPG diffuse vs local by core laboratory μQFR-based residual functional SYNTAX score rFSSQFR 0 vs 1 by core laboratory learning experience of μQFRRWS first half vs second half of enrolled cases in each center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None