Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk … (NCT06853470) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial
China222 participantsStarted 2024-09-10
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as completed — has the data been published yet, and if so, what did it show about major adverse events in patients who received the SynFlow 3.0 device during high-risk PCI compared to those who didn't?
2Since this trial focused specifically on high-risk PCI procedures, how would my doctor define whether my own procedure would fall into that 'high-risk' category, and does that affect whether this device or approach might be relevant to my care?
3The trial measured 'major adverse events' as its main outcome — can my doctor explain what kinds of serious complications that typically includes in a high-risk PCI study, and how does that help us understand the safety profile of using this type of circulatory support device?
4Because this trial didn't have a traditional phase label, what does that tell us about where this device stands in the regulatory or approval process, and is the SynFlow 3.0 currently available outside of a research setting?
5Are there standard alternatives — like other mechanical circulatory support devices or a different surgical approach — that my doctor would compare against what this trial found before deciding on the best strategy for my procedure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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.