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

Launched by FORQALY MEDICAL (SHANGHAI) CO., LTD · Feb 28, 2025

Keywords

ClinConnect Summary

The PERSIST Ⅲ Study is a clinical trial that is investigating a new heart support device called SynFlow 3.0. This device is being tested to see if it can provide similar or even better support than a commonly used machine called ECMO during high-risk heart surgeries for patients with serious heart conditions. The main goal is to find out if SynFlow 3.0 is just as effective (or better) as ECMO, while also considering factors like safety and cost.

To participate in this trial, patients should be between the ages of 65 and 74 and need surgery for coronary artery disease (CAD). Specifically, they should have a weakened heart or certain types of blockages in their arteries that make surgery risky. Participants will receive close monitoring and follow-up care throughout the study, allowing researchers to gather important data on how well the SynFlow 3.0 device works compared to ECMO. If you or a loved one are considering joining this study, please discuss it with your healthcare provider to see if you meet the eligibility criteria.

Gender

ALL

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.