High Risk PCIPERSIST ⅢNCT06853470

Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial

A study testing VA-ECMO circulatory support, SynFlow 3.0 circulatory support and percutaneous coronary intervention in people with High Risk PCI and Coronary Arterial Disease (CAD), run by ForQaly Medical (Shanghai) Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: High Risk PCI, Coronary Arterial Disease (CAD)
What is being tested?: VA-ECMO circulatory support, SynFlow 3.0 circulatory support and percutaneous coronary intervention
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 1 siteChina
Study dates: 10 Sep 2024to 13 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The investigator assesses that the subject requires coronary revascularization, but CABG is considered as high-risk or the subject refuses CABG. The investigator considers the subject may benefit from PCI.
Left ventricular ejection fraction (LVEF) ≤ 35%.
Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:
last patent conduit (occluded vessel diameter ≥ 2.5 mm).
unprotected left main (LM) coronary artery disease.
Three-vessel disease (stenosis ≥ 70%). *Three-vessel disease is defined as at least one significant stenosis (≥ 70%) lesion in all three major epicardial coronary artery territories: left anterior descending artery (LAD) and/or its branches, left circumflex artery (LCX) and/or its branches, and right coronary artery (RCA) and/or its branches. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualified as three-vessel disease.
The subject is able to understand the purpose of the trial and sign the informed consent form, and is likely to be compliant to and willing to receive the clinical follow up after discharge.

Who cannot join

STEMI within 24 hours.
Cardiac arrest within 24 hours.
Cardiogenic shock (CS) or acute decompensation of chronic heart failure (Cardiogenic shock is defined as systemic hypotension [systolic blood pressure <90 mmHg or requiring inotropes/vasopressors to maintain systolic blood pressure >90 mmHg] and any of the followings: ongoing need for inotropes/vasopressors before entering the catheterization lab, any clinical evidence of end-organ hypoperfusion, or use of IABP or other circulatory support devices).
History of stroke or TIA within one month prior to the procedure.
Contraindications to or inability to place pVAD and ECMO (including but not limited to: left ventricular thrombus, presence of a mechanical aortic valve or cardiac contractile device, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, stents in peripheral access or severe peripheral vascular disease such as tortuosity and dissection which impedes device placement, aortic dissection, aortic aneurysm, or severe abnormalities of ascending aorta or aortic arch , hematological diseases causing fragility of blood cells or hemolysis , hypertrophic obstructive cardiomyopathy).
Presence or suspicion of active systemic infection.

Show all 14Show fewer

Known contraindications to heparin (including heparin-induced thrombocytopenia), contrast agents, or study-required medications (e.g., aspirin, clopidogrel).
Uncorrectable coagulopathy prior to the procedure, including platelet count ≤75×10^9^/L or INR ≥2.0.
Liver dysfunction: liver enzymes and bilirubin of more than 3 times the upper limit of the normal value.
Renal dysfunction: undergoing dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L).
Severe right heart failure or severe tricuspid regurgitation.
Pregnant or lactating women, or women planning pregnancy during the trial.
Participation in another drug or medical device clinical trial without reaching the primary endpoint.
Other conditions deemed by the investigator as unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Safety and Efficacy of the SynFlow 3.0 Percutaneous Transvalvular Ventricular Assist System in Patients Undergoing High-Risk PCI: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial (PERSIST Ⅲ Study)

This study is conducted to compare the effectiveness of a new percutaneous mechanical circulatory support device called SynFlow 3.0 with VA-ECMO in high-risk percutaneous coronary intervetnion(PCI) patients. The objective of this study is to see if SynFlow 3.0 can provide similar or better support during high-risk PCI compared to VA-ECMO.

Specifically, the following questions is to be answered in this study:

Can SynFlow 3.0 provide sufficient hemodynamic support for patients during high-risk PCI and the effect be similar to VA-ECMO? Does SynFlow 3.0 offer other clinical benefits compared to VA-ECMO? By answering these questions, it will be determined if SynFlow 3.0 can be a viable alternative to VA-ECMO for patients undergoing high-risk PCI.

Read the detailed description

The study is a prospective, multicenter, randomized controlled trial under the Good Clinical Principles(GCP) carried out in more than 15 research centers over China. Patients with 3-vessel disease, unprotected left main coronary artery disease or last patent conduit and severly depressed left ventricular function (LVEF≤35%) will be enrolled and undergo non-emergent PCI, and be randomized 1:1 to receive either the SynFlow 3.0 or VA-ECMO support during the PCI. The primary endpoint is the incidence of 30-day major adverse events.

Conditions: High Risk PCI, Coronary Arterial Disease (CAD)
Being tested: VA-ECMO circulatory support, SynFlow 3.0 circulatory support, percutaneous coronary intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VA-ECMO circulatory supportDevice
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a percutaneous mechanical circulatory support device that can provide short-term hemodynamic support during high-risk PCI.
SynFlow 3.0 circulatory supportDevice
The SynFlow 3.0 is a novel percutaneous left ventricular-assist device that can provide temporary hemodynamic support during high-risk procedure.
percutaneous coronary interventionProcedure or surgery
The percutaneous coronary intervention is a percutaneous endovascular intervention technique that can restore coronary blood flow by various intervention methods such as angioplasty and stent implantation.

Study groups in NCT06853470
Study group	Role	What they receive
SynFlow3.0	Experimental	The patients will undergo PCI and use SynFlow3.0 as hemodynamic supoort during the PCI Receives: Device: SynFlow 3.0 circulatory support; Procedure: percutaneous coronary intervention
V-A ECMO	Active comparator	The patient will receive PCI and use V-A ECMO as hemodynamic support during the PCI Receives: Device: VA-ECMO circulatory support; Procedure: percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Major Adverse Events (MAE)
Measured: Up to 30 days

Secondary outcomes (8)

Incidence of MAE
Measured: Up to 90 days
Incidence of major adverse cardiac and cerebral events (MACCE)
Measured: Up to 30 days, up to 90days
the change of left ventricular ejection fraction (LVEF) compared to baseline
Measured: before discharge, at 30±7 days, at 90±14 days
the change of New York Heart Association (NYHA) class compared to baseline
Measured: before discharge, at 30±7 days, at 90±14 days
Total length of hospital stay
Measured: Up to 30 days
ICU/CCU length of stay
Measured: Up to 30 days
Incidence of adverse events
Measured: Up to 90 days
Incidence of serious adverse events
Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202413 Aug 2025

First posted3 Mar 2025
Study start10 Sep 2024
Primary completion27 May 2025
Study completion13 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for High Risk PCIStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06853470
Sponsor's protocol ID: HRPR002
Acronym: PERSIST Ⅲ
Status last verified: Aug 2026
First submitted: 19 Feb 2025
Last updated: 5 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhao G, Zhou S, Fang Z, Ma J, Tian F, Song D, Xu C, Yuan Z, Guo N, Zhao L, Zhang T, Wang J, Liu J, Yang Y, Yu X, Li Y, Zhang D, Gao C, Ye F, Zhang C, Yang J, Xiu J, Wang Q, Luan B, Tao J, Bai M, Yang R, Guo Y, Wang Y, Dai M, Wang J, Qian J, Chen Y, Ge J. Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial. Eur Heart J. 2026 Jul 29:ehag520. doi: 10.1093/eurheartj/ehag520. Online ahead of print.
PubMed 42521444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Recruiting
ELEVATE High-Risk PCI Pivotal Study
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
RecruitingPhase 4
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Recruiting
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
High-risk PCI
RecruitingObservational study
IVUS CHIP UPP Registry
Coronary Artery Disease, Coronary Artery Disease Risk High

All High Risk PCI trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of the SynFlow 3.0 Percutaneous Transvalvular Ventricular Assist System in Patients Undergoing High-Risk PCI: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial (PERSIST Ⅲ Study)
ClinicalTrials.gov ID: NCT06853470
Acronym / sponsor ID: PERSIST Ⅲ / HRPR002
Conditions: High Risk PCI, Coronary Arterial Disease (CAD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: ForQaly Medical (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
Study start: 10 Sep 2024 (actual)
Primary completion: 27 May 2025 (actual)
Study completion: 13 Aug 2025 (actual)
First posted: 3 Mar 2025 (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.

Specifically, the following questions is to be answered in this study:

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SynFlow3.0	Experimental	Device: SynFlow 3.0 circulatory support, Procedure: percutaneous coronary interventionThe patients will undergo PCI and use SynFlow3.0 as hemodynamic supoort during the PCI
V-A ECMO	Active comparator	Device: VA-ECMO circulatory support, Procedure: percutaneous coronary interventionThe patient will receive PCI and use V-A ECMO as hemodynamic support during the PCI

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The investigator assesses that the subject requires coronary revascularization, but CABG is considered as high-risk or the subject refuses CABG. The investigator considers the subject may benefit from PCI.
Left ventricular ejection fraction (LVEF) ≤ 35%.
Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:
The subject is able to understand the purpose of the trial and sign the informed consent form, and is likely to be compliant to and willing to receive the clinical follow up after discharge.

Key exclusion criteria (14 listed)

STEMI within 24 hours.
Cardiac arrest within 24 hours.
Cardiogenic shock (CS) or acute decompensation of chronic heart failure (Cardiogenic shock is defined as systemic hypotension [systolic blood pressure <90 mmHg or requiring inotropes/vasopressors to maintain systolic blood pressure >90 mmHg] and any of the followings: ongoing need for inotropes/vasopressors before entering the catheterization lab, any clinical evidence of end-organ hypoperfusion, or use of IABP or other circulatory support devices).
History of stroke or TIA within one month prior to the procedure.
Contraindications to or inability to place pVAD and ECMO (including but not limited to: left ventricular thrombus, presence of a mechanical aortic valve or cardiac contractile device, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, stents in peripheral access or severe peripheral vascular disease such as tortuosity and dissection which impedes device placement, aortic dissection, aortic aneurysm, or severe abnormalities of ascending aorta or aortic arch , hematological diseases causing fragility of blood cells or hemolysis , hypertrophic obstructive cardiomyopathy).

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
VA-ECMO circulatory supportVenoarterial extracorporeal membrane oxygenation (VA-ECMO) is a percutaneous mechanical circulatory support device that can provide short-term hemodynamic support during high-risk PCI.	Device	V-A ECMO
SynFlow 3.0 circulatory supportThe SynFlow 3.0 is a novel percutaneous left ventricular-assist device that can provide temporary hemodynamic support during high-risk procedure.	Device	SynFlow3.0
percutaneous coronary interventionThe percutaneous coronary intervention is a percutaneous endovascular intervention technique that can restore coronary blood flow by various intervention methods such as angioplasty and stent implantation.	Procedure or surgery	SynFlow3.0, V-A ECMO

Primary outcome

Incidence of Major Adverse Events (MAE)
Time frame: Up to 30 days

8 secondary outcomes

Incidence of MAE
Time frame: Up to 90 days
Incidence of major adverse cardiac and cerebral events (MACCE)
Time frame: Up to 30 days, up to 90days
the change of left ventricular ejection fraction (LVEF) compared to baseline
Time frame: before discharge, at 30±7 days, at 90±14 days
the change of New York Heart Association (NYHA) class compared to baseline
Time frame: before discharge, at 30±7 days, at 90±14 days
Total length of hospital stay
Time frame: Up to 30 days
ICU/CCU length of stay
Time frame: Up to 30 days
Incidence of adverse events
Time frame: Up to 90 days
Incidence of serious adverse events
Time frame: Up to 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Results publication: PubMed 42521444Zhao G, Zhou S, Fang Z, Ma J, Tian F, Song D, Xu C, Yuan Z, Guo N, Zhao L, Zhang T, Wang J, Liu J, Yang Y, Yu X, Li Y, Zhang D, Gao C, Ye F, Zhang C, Yang J, Xiu J, Wang Q, Luan B, Tao J, Bai M, Yang R, Guo Y, Wang Y, Dai M, Wang J, Qian J, Chen Y, Ge J. Micro-axial flow pump vs veno-arterial extracorporeal membrane oxygenation for high-risk percutaneous coronary interventions: a randomized trial. Eur Heart J. 2026 Jul 29:ehag520. doi: 10.1093/eurheartj/ehag520. Online ahead of print.

Related trials for High Risk PCI

Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Recruiting
ELEVATE High-Risk PCI Pivotal Study
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
RecruitingPhase 4
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Recruiting
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
High-risk PCI
RecruitingObservational study
IVUS CHIP UPP Registry
Coronary Artery Disease, Coronary Artery Disease Risk High

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. This study is not recruiting at the moment.

Jianan Wang, Phd principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

Dan Song, Phd principal investigator

Wuhan Asia Heart Hospital

Bo Luan, Phd principal investigator

Liaoning Provincial People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 14 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: finished, as of the sponsor's last update on 5 Aug 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Major Adverse Events (MAE) (time frame: Up to 30 days). 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 NCT06853470, which also lists 1 linked publication.

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 5 Aug 2026.