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

NCT06853470 | Completed DMC

• 1 other identifier: HRPR002
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Risk PCI; Coronary Arterial Disease (CAD)

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

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 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

Device: VA-ECMO circulatory support; Procedure: percutaneous coronary intervention

Interventions

VA-ECMO circulatory support DEVICE

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 support DEVICE

The SynFlow 3.0 is a novel percutaneous left ventricular-assist device that can provide temporary hemodynamic support during high-risk procedure.

SynFlow3.0

percutaneous coronary intervention PROCEDURE

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.

SynFlow3.0; V-A ECMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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%.
• 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.

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.

Sponsors & Collaborators

• ForQaly Medical (Shanghai) Co., Ltd: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jianan Wang, Phd

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  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

• Cheng Zhang, Phd

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Jingping Wang, Phd

  Shanxi Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

• Zuyi Yuan, Phd

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Yining Yang, Phd

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

• Yan Wang

  Xiamen Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

• Yan Li, Phd

  The Second Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

• Yansong Guo, Phd

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Ming Bai, Phd

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Renqiang Yang, Phd

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Jiancheng Xiu, Phd

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Jianhong Tao, Phd

  Sichuan Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Min Dai, Phd

  Mianyang Central Hospital

  PRINCIPAL INVESTIGATOR

• Lin Zhao, Phd

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• Yundai Chen, Phd

  First Medical Center of the General Hospital of the People's Liberation Army

  STUDY CHAIR

• Junbo Ge, Phd

  Shanghai Zhongshan Hospital

  STUDY CHAIR

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
• Primary Completion: May 27, 2025
• Study Completion: August 13, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)