An interventional study of FAST Technique and Angiography in ST-Segment Elevation Myocardial Infarction, Multivessel Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Diagnostic
Among 146 studies in ST Elevation Myocardial Infarction with a site in China — 42 open to participants now, 44 under way, 2 of them phase 3. ST Elevation Myocardial Infarction · China.
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, this one is the 7th largest by planned enrollment of the 97 interventional ones, is one of 8 that started in 2023, is one of 51 with no phase, reaches primary completion later than 34 of the 42 other live ones, and was the 106th registered.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →42 of the 146 studies in ST Elevation Myocardial Infarction with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →146 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 8 started in 2023.
Median enrollment 320 across the 97 interventional studies, 737 across the 48 observational. Of the 39 that completed or were terminated, 1 (3%) have results posted.
12 of 146 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
China National Center for Cardiovascular Diseases has 4 studies filed under ST Elevation Myocardial Infarction — fewer than ten, so there is no comparison to draw.
17 of the studies in ST Elevation Myocardial Infarction with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT06794801LanZhou UniversityEvaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study | 2026-12 |
| NCT05967663RenJi HospitalFractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study) | 2026-12 |
| NCT06339021Shenyang Northern HospitalOCT or Angiography Guided De-escalation of DAPT | 2026-12-01 |
| NCT06548204Second Affiliated Hospital, Zhejiang University, School of MedicineEffect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial | 2026-12-30 |
Among the 146 studies in ST Elevation Myocardial Infarction with a site in China, from their registry updates:
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).
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General inclusion
Angiographic inclusion:
Exclusion Criteria:
General exclusion
Angiographic exclusion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: FAST Technique · Diagnostic Test: Angiography
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.
Diagnostic Test: Angiography
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.
Also known as: The next-generation quantitative flow ratio and radial wall strain
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.
Also known as: Coronary angiography
Incidence of major adverse cardiac events (MACE)
Defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization
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)
Incidence of cardiovascular death and MI (Major secondary endpoint）
Defined as a composite of cardiovascular death and MI
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
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)
Time frame: Immediately post the PCI procedure
Rate of procedural success
Defined as lesion success in all treated lesions without in-hospital MACE
Time frame: Maximum of 7 days
Incidence of death
Including cardiovascular, non-cardiovascular or undetermined
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months, 1 year, 3 years, 5 years
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Jun 2028, 65 months after the start.
Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 65 months is above that.
Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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ST Elevation Myocardial Infarction →
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