ST-Segment Elevation Myocardial InfarctionNCT05669222
The FAVOR V AMI Trial
A study testing FAST Technique and Angiography in people with ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- FAST Technique and Angiography
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 30 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion
- Age ≥18 years
- STEMI ≤30d
- Successful primary PCI of all culprit lesion(s) responsible for the STEMI (visually-assessed residual stenosis <30% in stent-treated lesions or <50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in all treated vessels)
- No MACE event between the index PCI and the staged randomized procedure
- Able to understand the trial design and provide written informed consent
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- Angiographic inclusion:
- The presence of at least 1 non-culprit lesion with DS% 50%-90% in any non-infarct related artery with RVD ≥2.5 mm by visual assessment
- Non-culprit lesions are potentially eligible for PCI Note: All lesions in the infarct related arteries with DS ≥70% and RVD ≥2.5 mm by visual assessment must be successfully treated either during the index primary PCI or the staged procedure prior to randomization Note: There may also be 1 or more NCL with DS% >90% (including a CTO) as long as there is at least 1 NCL with DS% 50%-90% as above. Any such lesions in which PCI is intended must be treated successfully either during the index primary PCI or the staged procedure prior to randomization.
Who cannot join
- General exclusion
- Cardiogenic shock or refractory hypotension (Killip IV)
- On pressors or use of or need for intra-aortic balloon pump or other mechanical circulatory support devices
- Intubated
- Prior thrombolytic therapy for this admission
- Cockcroft-Gault-calculated CrCl <30 ml/kg
Show all 16Show fewer
- Pregnant or woman of child-bearing potential
- Life expectancy less than 1 year for non-cardiac causes
- Allergy to iodine-containing contrast agents which cannot be adequately premedicated
- Unable to tolerate DAPT for at least 6 months
- Prior CABG or planned CABG
- Any planned surgery within 6 months
- Any condition that may interfere with any follow-up procedures (e.g. dementia, drug use)
- Angiographic exclusion
- Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μQFR or RWS measurement
- Unable to judge culprit lesion or infarct-related artery according to current evidence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
Beijing, Beijing Municipality, 100037
Lei Song, MD, 13910968125, lsong@fuwai.com
Changdong Guan, MSc, 13220189487, cdguan@citmd.com
About this study
Official title: Functional and Angiography-Derived Strain Guided Multi-Vessel/Lesion Revascularization Strategy in Patients With Acute ST-Segment Elevation Myocardial Infarction (FAVOR V AMI)
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).
Read the 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 (μQFR+RWS) guided PCI strategy is superior to a standard treatment strategy by the primary and major secondary endpoint.
For the patients randomized to μQFR+RWS 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) ≥2.5 mm. If μQFR ≤0.80 or RWS ≥13%, PCI will be performed; if μQFR >0.80 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 <0.90, 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 ≥2.5 mm; for a non-culprit lesion with visually DS% 50-70%, PCI can be performed if fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. All patients will be followed by either telephone or clinic visit at 1 month, 6 months,1 year, 2 years, 3 years, 4 years and 5 years.
The sample size will be about 5,000 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 (0/1 vs. 2 vs. 3), infarct related artery (LM/LAD vs, others), untreated CTOs with RVD ≥2.5 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 (LM/LAD vs. others), diseased vessels (two-vessel disease vs. LM/three-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 < 0.75 vs. = 0.75-0.85 vs. > 0.85 [by core laboratory]), μQFR-based functional SYNTAX score (FSSQFR, low tertile vs. mid tertile vs. high tertile [by core laboratory]), post-PCI μQFR (≥0.90 vs. <0.90 [by core laboratory]), angiography-derived IMR (≥2.5 mmHgs/cm vs. <2.5 mmHgs/cm [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 μQFR/RWS (first half vs. second half of enrolled cases in each center).
- Conditions
- ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
- Being tested
- FAST Technique, Angiography
- Keywords
- Quantitative Flow Ratio, ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention, Radial Wall Strain
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST TechniqueDiagnostic test
Also called The next-generation quantitative flow ratio and radial wall strain
The next-generation QFR (μQFR) introduces a more intelligent algorithm and supports single-projection rapid calculation with a diagnostic accuracy of 93.0% compared with FFR; Computational RWS technique facilitates the assessment of lesion vulnerability.
AngiographyDiagnostic test
Also called Coronary angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.
| Study group | Role | What they receive |
|---|---|---|
| FAST Guided Strategy (μQFR+RWS) | Experimental | 1. μQFR is measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed DS% ≥50% and ≤90% with RVD ≥2.5 mm.
1. μQFR ≤0.80: PCI
2. RWS ≥13%: PCI
3. μQFR >0.80 and RWS <13%: Deferral
4. DS% >90%: PCI without the need of μQFR or RWS
2. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR <0.90, 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. Receives: Diagnostic Test: FAST Technique; Diagnostic Test: Angiography |
| Standard Treatment Strategy | Sham comparator | 1. PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm;
2. For a non-culprit lesion with visually DS% 50-70%, PCI can be performed if FFR ≤0.80 or iFR ≤0.89. Receives: Diagnostic Test: Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiac events (MACE)
Defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization
Measured: From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)
Secondary outcomes (11)
Incidence of cardiovascular death and MI (Major secondary endpoint）
Defined as a composite of cardiovascular death and MI
Measured: From the date of first randomization until a total number of 395 events of cardiovascular death and MI is reached (median follow-up of approximately 3 years)
Rate of lesion success
Defined as: 1) angiographic success (core laboratory-assessed residual stenosis <30% in stent-treated lesions or <50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in the treated vessel); and 2) physiological success (post-PCI μQFR ≥0.80 assessed by core lab)
Measured: Immediately post the PCI procedure
Rate of procedural success
Defined as lesion success in all treated lesions without in-hospital MACE
Measured: Maximum of 7 days
Incidence of death
Including cardiovascular, non-cardiovascular or undetermined
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of all MI
Including periprocedural MI (SCAI definition) and spontaneous MI (target vessel-related or non-target vessel-related, culprit lesion-related or non-culprit lesion-related)
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of any revascularization
Including ischemia-driven or non-ischemia driven, target vessel-related or non-target vessel-related, culprit lesion-related or non-culprit lesion-related
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of definite/probable stent thrombosis (ARC-2)
By ARC-2 definition and including acute, subacute, late and very late stent thrombosis
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Angina status evaluation
As assessed by the Seattle Angina Questionnaire (SAQ)
Measured: 6 months, 1 year, 3 years, 5 years
Health-related quality of life evaluation
As assessed by the European Quality of Life-5 Dimensions (EQ-5D)
Measured: 6 months, 1 year, 3 years, 5 years
Cost-effectiveness evaluation
As assessed by the Incremental cost effectiveness ratio (ICER) using the composite endpoint (including myocardial infarction, any revascularization, stent thrombosis, cerebrovascular and major bleeding events)
Measured: 6 months, 1 year, 3 years, 5 years
Cost-utility evaluation
As assessed by the Incremental cost-utility ratio (ICUR) using quality-adjusted life years (QALYs)
Measured: 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start17 Jan 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ST-Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bo Xu, MBBS, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, ShenzhenLei Song, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669222
- Sponsor's protocol ID
- FAVOR V AMI
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
PubMed 21247313Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
PubMed 33714389Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
PubMed 31475795Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
PubMed 33999545Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
PubMed 34742368Tu S, Ding D, Chang Y, Li C, Wijns W, Xu B. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:1040-1047. doi: 10.1002/ccd.29592. Epub 2021 Mar 4.
PubMed 33660921Hong H, Li C, Gutierrez-Chico JL, Wang Z, Huang J, Chu M, Kubo T, Chen L, Wijns W, Tu S. Radial wall strain: a novel angiographic measure of plaque composition and vulnerability. EuroIntervention. 2022 Sep 8;18(12):1001-10. doi: 10.4244/EIJ-D-22-00537. Online ahead of print.
PubMed 36073027
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Angiography-Derived Strain Guided Multi-Vessel/Lesion Revascularization Strategy in Patients With Acute ST-Segment Elevation Myocardial Infarction (FAVOR V AMI)
- ClinicalTrials.gov ID
- NCT05669222
- Acronym / sponsor ID
- FAVOR V AMI
- Conditions
- ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
- Keywords
- Quantitative Flow Ratio, ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention, Radial Wall Strain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (μQFR+RWS) guided PCI strategy is superior to a standard treatment strategy by the primary and major secondary endpoint.
For the patients randomized to μQFR+RWS 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) ≥2.5 mm. If μQFR ≤0.80 or RWS ≥13%, PCI will be performed; if μQFR >0.80 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 <0.90, 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 ≥2.5 mm; for a non-culprit lesion with visually DS% 50-70%, PCI can be performed if fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. All patients will be followed by either telephone or clinic visit at 1 month, 6 months,1 year, 2 years, 3 years, 4 years and 5 years.
The sample size will be about 5,000 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 (0/1 vs. 2 vs. 3), infarct related artery (LM/LAD vs, others), untreated CTOs with RVD ≥2.5 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 (LM/LAD vs. others), diseased vessels (two-vessel disease vs. LM/three-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 < 0.75 vs. = 0.75-0.85 vs. > 0.85 [by core laboratory]), μQFR-based functional SYNTAX score (FSSQFR, low tertile vs. mid tertile vs. high tertile [by core laboratory]), post-PCI μQFR (≥0.90 vs. <0.90 [by core laboratory]), angiography-derived IMR (≥2.5 mmHgs/cm vs. <2.5 mmHgs/cm [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 μQFR/RWS (first half vs. second half of enrolled cases in each center).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST Guided Strategy (μQFR+RWS) | Experimental | Diagnostic Test: FAST Technique, Diagnostic Test: Angiography1. μQFR is measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed DS% ≥50% and ≤90% with RVD ≥2.5 mm. 1. μQFR ≤0.80: PCI 2. RWS ≥13%: PCI 3. μQFR >0.80 and RWS <13%: Deferral 4. DS% >90%: PCI without the need of μQFR or RWS 2. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR <0.90, 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. |
| Standard Treatment Strategy | Sham comparator | Diagnostic Test: Angiography1. PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm; 2. For a non-culprit lesion with visually DS% 50-70%, PCI can be performed if FFR ≤0.80 or iFR ≤0.89. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- General inclusion
- Angiographic inclusion:
Key exclusion criteria (16 listed)
- General exclusion
- Angiographic exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAST TechniqueAlso: The next-generation quantitative flow ratio and radial wall strainThe next-generation QFR (μQFR) introduces a more intelligent algorithm and supports single-projection rapid calculation with a diagnostic accuracy of 93.0% compared with FFR; Computational RWS technique facilitates the assessment of lesion vulnerability. | Diagnostic test | FAST Guided Strategy (μQFR+RWS) |
| AngiographyAlso: Coronary angiographyCoronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries. | Diagnostic test | FAST Guided Strategy (μQFR+RWS), Standard Treatment Strategy |
Primary outcome
Incidence of major adverse cardiac events (MACE)
Time frame: From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)
Defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization
11 secondary outcomes
Incidence of cardiovascular death and MI (Major secondary endpoint）
Time frame: From the date of first randomization until a total number of 395 events of cardiovascular death and MI is reached (median follow-up of approximately 3 years)
Rate of lesion success
Time frame: Immediately post the PCI procedure
Rate of procedural success
Time frame: Maximum of 7 days
Incidence of death
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of all MI
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of any revascularization
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of definite/probable stent thrombosis (ARC-2)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Angina status evaluation
Time frame: 6 months, 1 year, 3 years, 5 years
Health-related quality of life evaluation
Time frame: 6 months, 1 year, 3 years, 5 years
Cost-effectiveness evaluation
Time frame: 6 months, 1 year, 3 years, 5 years
Cost-utility evaluation
Time frame: 6 months, 1 year, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 21247313Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
- Background: PubMed 33714389Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
- Background: PubMed 31475795Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
- Background: PubMed 33999545Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
- Background: PubMed 34742368Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
- Background: PubMed 33660921Tu S, Ding D, Chang Y, Li C, Wijns W, Xu B. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:1040-1047. doi: 10.1002/ccd.29592. Epub 2021 Mar 4.
- Background: PubMed 36073027Hong H, Li C, Gutierrez-Chico JL, Wang Z, Huang J, Chu M, Kubo T, Chen L, Wijns W, Tu S. Radial wall strain: a novel angiographic measure of plaque composition and vulnerability. EuroIntervention. 2022 Sep 8;18(12):1001-10. doi: 10.4244/EIJ-D-22-00537. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Xu, MBBS principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen
Lei Song, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST Technique and Angiography in people with ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Xu, MBBS (+86-10-88322562, bxu@citmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiac events (MACE) (time frame: From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669222, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.