Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction

NCT07678021 | Not Yet Recruiting DMC

• 1 other identifier: 2025-2847
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump） for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction. Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled. The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy. This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.

Conditions

Coronary Artery Disease (CAD)

Keywords

Left ventricular assist system; complex coronary heart disease; left ventricular dysfunction; randomized controlled study

Outcome Measures

Primary Outcomes (1)

• 1-year MACCE

  a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure

  Up to 1 year after enrollment

Secondary Outcomes (4)

• Perioperative myocardial infarction

  Up to 48h after the index PCI procedure

• Types 3, 4, and 5 bleeding as defined by MCS-ARC

  Up to 1 year after enrollment

• Severe hemolysis related to the device

  Up to 72 hours after the implantation of the CorVad left ventricular assist system

• Stent thrombosis

  Up to 1 year after the index PCI procedure

Study Arms (2)

Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm

EXPERIMENTAL

Participants assigned to the intervention arm will undergo PCI supported by the micro-axial flow pump, in addition to optimal medical therapy (OMT).

Device: Microaxial pump-supported PCI; Drug: Optimal medical therapy (OMT)

Optimal medical therapy (OMT) alone arm

OTHER

Participants in this arms will receive guideline-directed optimal medical therapy (OMT) as determined by the heart failure team at each center.

Drug: Optimal medical therapy (OMT)

Interventions

Microaxial pump-supported PCI DEVICE

Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients

Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm

Optimal medical therapy (OMT) DRUG

Guideline-directed OMT will be determined by the heart failure team at each center. OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities. Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat.

Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm; Optimal medical therapy (OMT) alone arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is aged ≥18 years;
• The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction \<35%;
• After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
• The subject has signed an informed consent form approved by the ethics committee, has good compliance after discharge, and is willing to undergo clinical follow-up.
• At least two vascular occlusive lesions (with the diameter of the occluded vessel \>2.5mm) or unprotected left main coronary artery disease, and meeting one or more complex procedural criteria, or three-vessel disease, and meeting two or more complex procedural criteria;

You may not qualify if:

• Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
• Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
• Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
• Patients with cardiogenic shock or hemodynamic instability;
• Cardiopulmonary resuscitation was performed before randomization;
• Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction;
• The mechanical circulatory assist device cannot be implanted or there are contraindications (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contractile device, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, presence of stents in peripheral vascular access, tortuosity, dissection, and other severe vascular lesions that hinder the implantation of the investigational device, aortic aneurysm or severe malformation abnormalities, blood cell fragility or hemolytic blood system diseases, hypertrophic or hypertrophic obstructive cardiomyopathy, etc.);
• Severe abnormalities in platelets, with a count below 50×10\^9/L or above 600×10\^9/L;
• Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month;
• Unable to use antiplatelet or anticoagulant drugs;
• Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications;
• Severe renal insufficiency, requiring or expected to require long-term dialysis treatment;
• Severe active infection, puncture site infection, sepsis, or septicemia;
• Life expectancy is less than or equal to 1 year;
• Women who are pregnant or breastfeeding;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kefei Dou, MD, PhD

CONTACT

+86-13801032912; drdoukefei@126.com

Guofeng Gao, MD

CONTACT

+8613811458815; ggf03@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: July 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-01

Locations

CN (1)