Evaluating a new heart support system for patients undergoing high-risk heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for providing short-term support during high-risk percutaneous coronary interventions (HRPCI) in patients with coronary artery disease. It is a prospective, multicenter, single-arm trial aiming to enroll 120 subjects who are hemodynamically stable and require PCI. The study will measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days post-procedure. Participants will be monitored closely to assess the system's performance and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing, China Recruiting
• The First Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Hunan Provincial People's Hospital
  Changsha, Hunan, China Recruiting
• China-Japan Union Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• Shanghai East Hospital of Tongji University
  Shanghai, Shanghai, China Recruiting

Study contacts

• Principal investigator: Ke Fei Dou — Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xiaoli Shi
• Email: shixiaoli@coretechmed.com
• Phone: +86 13418601356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.