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

NCT06754839 | Not Yet Recruiting

• 1 other identifier: XLMD-ZSFZ-QX02
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Heart Failure; High-risk PCI

Keywords

High-risk PCI; Percutaneous left ventricular assist device; heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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.

  30 days post-operation

• Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation.

  90 days post-operation

• Success rate of hemodynamic support during device use

  90 days post-operation

• The success rate of percutaneous coronary intervention(PCI)

  90 days post-operation

Study Arms (2)

Experimental group(Ventiflow LP)

EXPERIMENTAL

Device: Percutaneous left ventricular assist device(Ventiflow LP)

Control Group(VA-ECMO)

ACTIVE COMPARATOR

Device: VA-ECMO

Interventions

Percutaneous left ventricular assist device(Ventiflow LP) DEVICE

The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).

Experimental group(Ventiflow LP)

VA-ECMO DEVICE

The PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO).

Control Group(VA-ECMO)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years to 90 Years
• 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
• The subject is diagnosed with acute or chronic coronary syndrome, and
• LVEF≤ 35% or
• LVEF ≤ 40% and NYHA Classification is III or IV
• Informed consent
• \. 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:
• Bifurcation lesions require treatment of dual branches (including stents and PTCA)
• Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)
• Severe distortion requires complex operations
• The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )

You may not qualify if:

• Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
• Cardiopulmonary resuscitation within 24 hours;
• 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;
• Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
• 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;
• Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;
• 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;
• History of stroke or transient ischemic attack within 1 month before surgery;
• Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;
• Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);
• 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;
• Active visceral hemorrhage within 1 month;
• History of allergy to heparin, contrast media, etc.;
• 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.;
• Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;

Sponsors & Collaborators

• Suzhou Hearthill Medical Technology Co.,LTD: lead

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yujie Zhou, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

• Yong He, MD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Yujie Zhou, MD

CONTACT

086-13901330652; azzyj12@163.com

Xiaoshen Yan

CONTACT

86-0512-87662295; kevin.yan@hearthillmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 1, 2025
• Study Start: December 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share