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

Micro-axial Flow Pump-Supported PCI Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Complex Coronary Artery Disease With Ischemic LV Dysfunction: A Prospective, Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: Microaxial pump-supported PCI; Drug: Optimal medical therapy (OMT)

• Study Type: Interventional
• Enrollment (Estimated): 452
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kefei Dou, MD, PhD; Phone Number: +86-13801032912; Email: drdoukefei@126.com
• Study Contact Backup: Name: Guofeng Gao, MD; Phone Number: +8613811458815; Email: ggf03@163.com

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Kefei Dou, MD, PhD; Phone Number: +86-1380103291; Email: drdoukefei@126.com
    • Principal Investigator: Kefei Dou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is aged ≥18 years;
2. The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction <35%;
3. After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
4. 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.
5. 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;

Exclusion Criteria:

1. Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
2. Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
3. Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
4. Patients with cardiogenic shock or hemodynamic instability;
5. Cardiopulmonary resuscitation was performed before randomization;
6. Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction;
7. 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.);
8. Severe abnormalities in platelets, with a count below 50×10^9/L or above 600×10^9/L;
9. Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month;
10. Unable to use antiplatelet or anticoagulant drugs;
11. Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications;
12. Severe renal insufficiency, requiring or expected to require long-term dialysis treatment;
13. Severe active infection, puncture site infection, sepsis, or septicemia;
14. Life expectancy is less than or equal to 1 year;
15. Women who are pregnant or breastfeeding;
16. Severe right heart failure or severe tricuspid regurgitation;
17. Participation in other clinical trials has not yet reached the primary endpoint;
18. Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm; 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; Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients; Drug: Optimal medical therapy (OMT); 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.
Other: Optimal medical therapy (OMT) alone arm; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: left ventricular dysfunction; randomized controlled study; Left ventricular assist system; complex coronary heart disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ventricular Dysfunction, Left; Coronary Artery Disease
• Other Study ID Numbers: 2025-2847

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No