A Prospective, Multicenter, Randomized, Non-inferiority Trial for Investigating Safety & Efficacy of SynFlow3.0 Assist System in High-risk PCI Patients (PERSIST Ⅲ Study)

Not Applicable

Recruiting

• Conditions: High Risk PCI; Coronary Arterial Disease (CAD)

• Registration Number: NCT06853470
• Lead Sponsor: ForQaly Medical (Shanghai) Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-10
• Primary Completion: 2024-09-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Material Adverse Events (MAE) within 30 days after surgery	From enrollment to 30 ±7 days after PCI surgery

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China