Trials Sponsors Conditions Drugs Pricing

Conditions

Coronary Arterial Disease (CAD)High Risk PCI

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

Incidence of MAE
Up to 90 days
Incidence of major adverse cardiac and cerebral events (MACCE)
Up to 30 days, up to 90days
the change of left ventricular ejection fraction (LVEF) compared to baseline
before discharge, at 30±7 days, at 90±14 days
the change of New York Heart Association (NYHA) class compared to baseline
before discharge, at 30±7 days, at 90±14 days
Total length of hospital stay
Up to 30 days
+3 more secondary outcomes

Study Arms (2)

SynFlow3.0

EXPERIMENTAL

The patients will undergo PCI and use SynFlow3.0 as hemodynamic supoort during the PCI

Device: SynFlow 3.0 circulatory supportProcedure: percutaneous coronary intervention

V-A ECMO

ACTIVE COMPARATOR

The patient will receive PCI and use V-A ECMO as hemodynamic support during the PCI

Device: VA-ECMO circulatory supportProcedure: percutaneous coronary intervention

Interventions

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.

V-A ECMO

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.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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%.

Sponsors & Collaborators

ForQaly Medical (Shanghai) Co., Ltd
Industrylead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Related Publications (1)

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.
PMID: 42521444RESULT

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

Jianan Wang, Phd
Second Affiliated Hospital, Zhejiang University, School of Medicine
PRINCIPAL INVESTIGATOR
Dan Song, Phd
Wuhan Asia Heart Hospital
PRINCIPAL INVESTIGATOR
Bo Luan, Phd
Liaoning Provincial People's Hospital
PRINCIPAL INVESTIGATOR
Chuanyu Gao, Phd
Fuwai Huazhong Cardiovascular Hospital
PRINCIPAL INVESTIGATOR

Enrollment

222 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 3, 2025

Study Start

September 10, 2024

Actual (reported)

You may not qualify if:

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.
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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

SynFlow3.0

V-A ECMO

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

SynFlow3.0

V-A ECMO

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations