CorVad Percutaneous Ventricular Assist System Study

NCT06198998 | Unknown

• 1 other identifier: COREMED_Corvad_HRPCI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.

  Major adverse events were defined as follows: death, new myocardial infarction, stroke, and target vessel revascularisation. Calculation formula: 30-day MACCE rate = Number of subjects experiencing any MACCE event within 30 days post-PCI ÷ Total number of subjects × 100%

  30 days post-PCI

Secondary Outcomes (7)

• Hemodynamic stability during PCI procedure

  During PCI procedure

• PCI procedural angiographic success rate

  Post-PCI

• Change of aortic valve regurgitation

  Pre-procedure and pre-discharge

• Change in creatinine clearance at 48 hours post-PCI

  Pre-procedure and 48 hours post-PCI

• Change in left ventricular ejection fraction (LVEF) pre- and post-PCI

  Pre-procedure, 48 hours post-PCI and pre-discharge

Study Arms (1)

CorVad Percutaneous Ventricular Assist System

EXPERIMENTAL

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

Device: CorVad Percutaneous Ventricular Assist System

Interventions

CorVad Percutaneous Ventricular Assist System DEVICE

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

CorVad Percutaneous Ventricular Assist System

Eligibility Criteria

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

You may qualify if:

• \. 18 years old≤ patient age ≤90 years old;
• \. Patient willing and able to comply with protocol requirements and data collection procedures; able to understand study purpose and sign informed consent;
• \. 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);
• \. The patient is hemodynamically stable and meeting one of the following:
• Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease, planning PCI to at least one complex lesion\* in a major epicardial vessel or branch;
• LVEF ≤35% and either:
• I. Unprotected left main intervention;
• II. Or last patent coronary conduit;
• 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.

You may not qualify if:

• \. ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
• \. Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
• \. Cardiogenic shock defined as meeting all of the following:
• Systolic blood pressure \<90mmHg, or requiring vasopressors/inotropes to maintain blood pressure \>90mmHg;
• Clinical evidence of end-organ hypoperfusion (cold extremities or urine output \<30ml/h), or use of IABP or other mechanical circulatory assist device;
• Cardiac index (CI) \<2.2L/min/m\^2 and pulmonary capillary wedge pressure (PCWP) \>15mmHg;
• \. Presence of left ventricular thrombus;
• \. Presence of mechanical aortic valve or cardiac contractility device;
• \. Presence of moderate-to-severe aortic valve stenosis;
• \. Presence of moderate-to-severe aortic valve insufficiency;
• \. 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;
• \. Presence of aortic vascular disease or aortic dissection;
• \. Presence of uncorrected, sustained ventricular arrhythmia causing inability to stable position percutaneous ventricular assist device;
• \. History of stroke with permanent neurological deficit, intracerebral hemorrhage, subdural hematoma, or conditions predisposing to intracranial hemorrhage such as arteriovenous malformation or mass;
• \. End-stage renal disease requiring dialysis or serum creatinine ≥4mg/dL;

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (12)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410002, China

RECRUITING

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

RECRUITING

Tangdu Hospital of Air Force Medical University

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Shanghai East Hospital of Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Xijing Hospital of Air Force Military Medical University

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ke Fei Dou

  Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Shi

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

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

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: January 10, 2024
• Study Start: October 19, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (12)