Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)

Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention

The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Heart Failure; High-risk PCI
• Intervention / Treatment: Device: Percutaneous left ventricular assist device(Ventiflow LP); Device: VA-ECMO

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoshen Yan; Phone Number: 86-0512-87662295; Email: kevin.yan@hearthillmedical.com
• Study Contact Backup: Name: Yujie Zhou, MD; Phone Number: 086-13901330652; Email: azzyj12@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 Years to 90 Years
2. The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI

3. The subject is diagnosed with acute or chronic coronary syndrome, and

   1. LVEF≤ 35% or
   2. LVEF ≤ 40% and NYHA Classification is III or IV
4. Informed consent
5. The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.

1. At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards

Complex operations are defined as:

1. Bifurcation lesions require treatment of dual branches (including stents and PTCA)
2. Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)
3. Severe distortion requires complex operations
4. The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )

Exclusion Criteria:

1. Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
2. Cardiopulmonary resuscitation within 24 hours;
3. Patients who have had cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;
4. Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
5. Presence of aortic stenosis/calcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;
6. Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;
7. Prior or current use of a persistent left ventricular assist device (LVAD), or use of IABP, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (such as Impella or Tandem Heart) within 7 days prior to surgery;
8. History of stroke or transient ischemic attack within 1 month before surgery;
9. Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;
10. Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);
11. Moderate and severe anemia (hemoglobin <90g/L); Subject has abnormalities in coagulation parameters that cannot be corrected (defined as platelet count ≤ 75×109/L or INR ≥2.0 or fibrinogen ≤1.50g/l); or inability to be treated with antiplatelet agents and anticoagulants;
12. Active visceral hemorrhage within 1 month;
13. History of allergy to heparin, contrast media, etc.;
14. Aortic abnormalities that preclude surgery, including aneurysms, extreme curvature, or calcification; or known severe arterial disease that precludes the trial, such as aortic dissection, Marfan syndrome, etc.;
15. Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;
16. Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;
17. Pregnant women and lactating women;
18. The subject has participated in other medical device clinical trials/drug clinical trials during the same period;
19. ECMO cannot be implanted or there are contraindications to its application and any other conditions that the investigator considers inappropriate to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group(Ventiflow LP)	Device: Percutaneous left ventricular assist device(Ventiflow LP); The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).
Active Comparator: Control Group(VA-ECMO)	Device: VA-ECMO; The PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events within 30 days post-operation.	Major adverse events are defined as death, stroke, myocardial infarction, revascularization, rehospitalization due to cardiovascular reasons, bleeding types 3, 4, 5 defined by mechanical circulatory support academic research consortium (MCS-ARC) , acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation.	30 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events within 90 days post-operation.		90 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-operation.	MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .	30 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation.	MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .	90 days post-operation
Success rate of hemodynamic support during device use	definition of successful hemodynamic support: successful delivery and initiation of the device, no hemodynamic deregulation occurs during the device support period (haemodynamic derangement refers to: mean arterial pressure(MAP ) less than 60 mmHg for more than 10 minutes and requires additional vasoactive drug therapy)	90 days post-operation
The success rate of percutaneous coronary intervention(PCI)	The success rate of PCI is defined as: residual stenosis < 30% after stent implantation or < 50% after balloon angioplasty, or thrombolysis in myocardial infarction(TIMI) flow grade 3.	90 days post-operation
Complete revascularization rate	Complete revascularization rate is defined as: residual SYNTAX score ≤8	Immediately after the intervention
Change in creatinine clearance		Baseline to 48 hours postoperation and 30 days post-operation
The change in left ventricular ejection fraction (LVEF) compared to baseline		Baseline to 30 days post-operation and 90 days post-operation
The change in New York heart association(NYHA) classification compared to baseline	The NYHA classification of heart function consists of four levels, ranging from I to IV, with heart function progressively deteriorating.	30 days post-operation, 90 days post-operation
Length of hospital stay within 30 days post-operation		30 days post-operation
Length of intensive care unit(ICU)/(coronary care unit)CCU stay within 30 days post-operation		30 days post-operation
Success rate of device operation	The system has delivered to the designated position and completed the pump start-up without any device failure.	30 days post-operation
Usage time of research device	The time from the start to the stop of the research device.	30 days post-operation
Device performance evaluation	The operator scores the device after use, with 5 being the best and 1 being the worst.	Intraoperation
The failure rate of the device	The failure rate of the device is defined as any component of the research equipment (Ventiflow LP or ECMO) system that is unable to operate according to its designed performance specifications .	Intraoperation
Incidence of serious adverse events	Incidence of serious adverse events: Serious adverse events refer to those that occur during the clinical trial process and result in death or a significant deterioration in health status, including fatal diseases or injuries, permanent impairment of bodily structure or function, and events that require medical or surgical intervention to prevent permanent impairment of bodily structure or function, among others.	90 days post-operation
The incidence of serious adverse events	The incidence of serious adverse events related to medical devices: including but not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), infections, damage to the aorta and aortic valve, hemolysis, complications requiring surgical intervention, and events leading to subject mortality, permanent or severe disability, significantly prolonged hospitalization, or the need for surgical intervention .	90 days post-operation

Collaborators and Investigators

• Sponsor: Suzhou Hearthill Medical Technology Co.,LTD
• Investigators: Study Chair: Yujie Zhou, MD, Beijing Anzhen Hospital; Study Chair: Yong He, MD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; High-risk PCI; Percutaneous left ventricular assist device
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Heart Failure; Coronary Artery Disease
• Other Study ID Numbers: XLMD-ZSFZ-QX02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No