Clinical trial NCT06853470: A Prospective, Multicenter, Randomized, Non-inferiority Trial for Investigating Safety & Efficacy of SynFlow3.0 Assist System in High-risk PCI Patients (PERSIST Ⅲ Study)
Official title: A Prospective, Multicenter, Randomized, Non-Inferiority Trial Investigating the Safety and Efficacy of the SynFlow3.0 Percutaneous Transvalvular Ventricular Assist System in Patients Undergoing High-Risk PCI (PERSIST Ⅲ Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk PCI
Coronary Arterial Disease (CAD)
Lead sponsor: ForQaly Medical (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are conducting a study to compare the effectiveness of a new heart support device called SynFlow 3.0 with ECMO (a commonly used heart and lung support machine) in patients with high-risk heart disease. The main goal of this study is to see if SynFlow 3.0 can provide similar or better support during heart surgeries compared to ECMO.

Specifically, we want to answer the following questions:

Can SynFlow 3.0 effectively support patients during heart surgeries, similar to ECMO? Is SynFlow 3.0 non-inferior to ECMO, meaning it is not worse than ECMO by a clinically acceptable margin? Does SynFlow 3.0 offer other benefits, such as better safety or lower costs, compared to ECMO? By answering these questions, we hope to determine if SynFlow 3.0 can be a viable alternative to ECMO for patients undergoing high-risk heart surgeries.


Eligibility criteria: Inclusion Criteria:

1. The investigator assesses that the subject requires coronary revascularization, but CABG is considered high-risk or the subject refuses CABG. The investigator believes 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. Single-vessel disease with an open lesion (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 significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and/or its branches, the left circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.
4. The subject understands the purpose of the trial, is able to provide informed consent, is likely to be compliant after discharge, and is willing to participate in clinical follow-up.

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: systemic hypotension \[systolic blood pressure \<90 mmHg or requiring inotropes/vasopressors to maintain systolic blood pressure \>90 mmHg\] and any of the following: ongoing need for inotropes/vasopressors before entering the catheterization lab, any clinical evidence of end-organ hypoperfusion, or use of IABP or other circulatory assist 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, severe peripheral vascular disease with stents, tortuosity, or dissections that impede device placement, aortic dissection, aneurysm, or severe aortic root/arch abnormalities, hemolytic blood disorders, 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 \>3 times the upper limit of normal.
10. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L).
11. Severe right heart failure or severe tricuspid regurgitation.
12. Women who are pregnant, breastfeeding, or 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.

Primary outcomes:
measure: Incidence of Material Adverse Events (MAE) within 30 days after surgery
timeFrame: From enrollment to 30 ±7 days after PCI surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Asia Heart Hospital
name: Dan Song, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Guoqiang Gu, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Provincial People's Hospital
name: Bo Luan, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai Huazhong Cardiovascular Hospital
name: Chuanyu Gao, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Qilu Hospital of Shandong University
name: Cheng Zhang, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Cardiovascular Hospital
name: Jingping Wang, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zuyi Yuan, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
name: Yining Yang, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiamen Cardiovascular Hospital
name: Yan Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second AffiliatThe Second Affiliated Hospital of Air Force Medical Universityed Hospital of Air Force Medical University
name: Yan Li, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Provincial Hospital
name: Yansong Li, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Ming Bai, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Nanchang University
name: Renqiang Yang, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Yong Bai, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Jiancheng Xiu, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Academy of Medical Sciences
name: Jianhong Tao, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Mianyang Central Hospital
name: Min Dai, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Lin Zhao, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: First Medical Center of the General Hospital of the People's Liberation Army
name: Yundai Chen, Phd
role: STUDY_DIRECTOR
References: