CorVad Percutaneous Ventricular Assist System Study

NCT ID: NCT06198998

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2024-10-18

Brief Summary

This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multicenter, single-arm clinical trial.

Detailed Description

This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects.

The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CorVad Percutaneous Ventricular Assist System

Subjects with coronary artery disease receiving high-risk PCI will be supported by the CorVad Percutaneous Ventricular Assist System during the procedure.

Group Type: EXPERIMENTAL

CorVad Percutaneous Ventricular Assist System

Intervention Type: DEVICE

The CorVad Percutaneous Ventricular Assist System provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.

Interventions

CorVad Percutaneous Ventricular Assist System

The CorVad Percutaneous Ventricular Assist System provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. 18 years old≤ patient age ≤90 years old;
• 2. Patient willing and able to comply with protocol requirements and data collection procedures; able to understand study purpose and sign informed consent;
• 3. As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG. After comprehensive evaluation, the cardiac team believes that the patient can benefit from PCI (Percutaneous Coronary Intervention);
• 4. The patient is hemodynamically stable and meeting one of the following:

1. Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease, planning PCI to at least one complex lesion* in a major epicardial vessel or branch;

2. LVEF ≤35% and either:

I. Unprotected left main intervention;

II. Or last patent coronary conduit;

3. LVEF ≤40%, planning PCI to at least one complex lesion* in a major epicardial vessel or branch. The intervention team confirms there is a risk of cardiac arrest or circulatory collapse. This must be confirmed by at least two associate senior physicians or one chief senior physician.

• Complex lesions include moderate-to-severe calcification, chronic total occlusions (CTO), diffuse disease, bifurcation lesions, severe tortuosity, etc.

Exclusion Criteria

• 1. ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
• 2. Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
• 3. Cardiogenic shock defined as meeting all of the following:

1. Systolic blood pressure <90mmHg, or requiring vasopressors/inotropes to maintain blood pressure >90mmHg;

2. Clinical evidence of end-organ hypoperfusion (cold extremities or urine output <30ml/h), or use of IABP or other mechanical circulatory assist device;

3. Cardiac index (CI) <2.2L/min/m^2 and pulmonary capillary wedge pressure (PCWP) >15mmHg;

• 4. Presence of left ventricular thrombus;
• 5. Presence of mechanical aortic valve or cardiac contractility device;
• 6. Presence of moderate-to-severe aortic valve stenosis;
• 7. Presence of moderate-to-severe aortic valve insufficiency;
• 8. Deemed unable to tolerate percutaneous ventricular assist device based on clinical or imaging assessment, including iliac/femoral artery diameter <6mm, severe tortuosity, severe bilateral iliofemoral/femoral artery disease, or other peripheral vascular disease;
• 9. Presence of aortic vascular disease or aortic dissection;
• 10. Presence of uncorrected, sustained ventricular arrhythmia causing inability to stable position percutaneous ventricular assist device;
• 11. History of stroke with permanent neurological deficit, intracerebral hemorrhage, subdural hematoma, or conditions predisposing to intracranial hemorrhage such as arteriovenous malformation or mass;
• 12. End-stage renal disease requiring dialysis or serum creatinine ≥4mg/dL;
• 13. Presence of potential bleeding diathesis or hypercoagulable state;
• 14. Pregnancy (for women of childbearing potential, pregnancy test required within 7 days prior to PCI procedure);
• 15. Presence of contraindication to anticoagulation;
• 16. History of liver failure, with ALT, AST, and bilirubin elevated to 3 times the upper limit of normal (ULN) or international normalized ratio (INR) ≥2;
• 17. Presence of uncorrected abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
• 18. Presence of uncontrolled active infection requiring antibiotic therapy;
• 19. Participation in any other clinical trial that may impact the results of this study;
• 20. Other circumstances that are unforeseen and determined by the investigator to be unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Core Medical Technology CO.,LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ke Fei Dou

Role: PRINCIPAL_INVESTIGATOR

Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences

Locations

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: NOT_YET_RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: NOT_YET_RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status: RECRUITING

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Tangdu Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Site Status: NOT_YET_RECRUITING

Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Xijing Hospital of Air Force Military Medical University

Xi’an, Shanxi, China

Site Status: NOT_YET_RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoli Shi

Role: CONTACT

shixiaoli@coretechmed.com

+86 13418601356

Facility Contacts

Ke Fei Dou

Role: primary

drdoukefei@126.com

Other Identifiers

COREMED_Corvad_HRPCI

Identifier Type: -

Identifier Source: org_study_id