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

NCT ID: NCT06853470

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-08-13

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SynFlow3.0

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

Group Type: EXPERIMENTAL

SynFlow 3.0 circulatory support

Intervention Type: DEVICE

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

percutaneous coronary intervention

Intervention Type: 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.

V-A ECMO

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

Group Type: ACTIVE_COMPARATOR

VA-ECMO circulatory support

Intervention Type: 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.

percutaneous coronary intervention

Intervention Type: 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.

Interventions

VA-ECMO circulatory support

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a percutaneous mechanical circulatory support device that can provide short-term hemodynamic support during high-risk PCI.

Intervention Type: DEVICE

SynFlow 3.0 circulatory support

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

Intervention Type: DEVICE

percutaneous coronary intervention

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Left ventricular ejection fraction (LVEF) ≤ 35%.

3. Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:

1. last patent conduit (occluded vessel diameter ≥ 2.5 mm).

2. unprotected left main (LM) coronary artery disease.

3. 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.

4. 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.

Exclusion Criteria

1. STEMI within 24 hours.

2. Cardiac arrest within 24 hours.

3. 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).

4. History of stroke or TIA within one month prior to the procedure.

5. 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).

6. Presence or suspicion of active systemic infection.

7. Known contraindications to heparin (including heparin-induced thrombocytopenia), contrast agents, or study-required medications (e.g., aspirin, clopidogrel).

8. Uncorrectable coagulopathy prior to the procedure, including platelet count ≤75×10^9^/L or INR ≥2.0.

9. Liver dysfunction: liver enzymes and bilirubin of more than 3 times the upper limit of the normal value.

10. Renal dysfunction: undergoing dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L).

11. Severe right heart failure or severe tricuspid regurgitation.

12. Pregnant or lactating women, or women planning pregnancy during the trial.

13. Participation in another drug or medical device clinical trial without reaching the primary endpoint.

14. Other conditions deemed by the investigator as unsuitable for participation in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ForQaly Medical (Shanghai) Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianan Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Dan Song, Phd

Role: PRINCIPAL_INVESTIGATOR

Wuhan Asia Heart Hospital

Bo Luan, Phd

Role: PRINCIPAL_INVESTIGATOR

Liaoning Provincial People's Hospital

Chuanyu Gao, Phd

Role: PRINCIPAL_INVESTIGATOR

Fuwai Huazhong Cardiovascular Hospital

Cheng Zhang, Phd

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Jingping Wang, Phd

Role: PRINCIPAL_INVESTIGATOR

Shanxi Cardiovascular Hospital

Zuyi Yuan, Phd

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Yining Yang, Phd

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Xinjiang Uygur Autonomous Region

Yan Wang

Role: PRINCIPAL_INVESTIGATOR

Xiamen Cardiovascular Hospital

Yan Li, Phd

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Air Force Medical University

Yansong Guo, Phd

Role: PRINCIPAL_INVESTIGATOR

Fujian Provincial Hospital

Ming Bai, Phd

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Renqiang Yang, Phd

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nanchang University

Jiancheng Xiu, Phd

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Jianhong Tao, Phd

Role: PRINCIPAL_INVESTIGATOR

Sichuan Academy of Medical Sciences

Min Dai, Phd

Role: PRINCIPAL_INVESTIGATOR

Mianyang Central Hospital

Lin Zhao, Phd

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Yundai Chen, Phd

Role: STUDY_CHAIR

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

Junbo Ge, Phd

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HRPR002

Identifier Type: -

Identifier Source: org_study_id