Coronary Artery Disease (CAD)PIVOTNCT07678021
Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction
A study testing Microaxial pump-supported PCI and Optimal medical therapy (OMT) in people with Coronary Artery Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- Microaxial pump-supported PCI and Optimal medical therapy (OMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
- Severe right heart failure or severe tricuspid regurgitation;
- Participation in other clinical trials has not yet reached the primary endpoint;
- Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Kefei Dou, MD, PhD, +86-1380103291, drdoukefei@126.com
Kefei Dou, MD, PhD
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- Microaxial pump-supported PCI, Optimal medical therapy (OMT)
- Keywords
- Left ventricular assist system, complex coronary heart disease, left ventricular dysfunction, randomized controlled study
- Medical subject headings
- Coronary Artery Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microaxial pump-supported PCIDevice
Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Optimal medical therapy (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year MACCE
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
Measured: Up to 1 year after enrollment
Secondary outcomes (4)
Perioperative myocardial infarction
Measured: Up to 48h after the index PCI procedure
Types 3, 4, and 5 bleeding as defined by MCS-ARC
Measured: Up to 1 year after enrollment
Severe hemolysis related to the device
Measured: Up to 72 hours after the implantation of the CorVad left ventricular assist system
Stent thrombosis
Measured: Up to 1 year after the index PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678021
- Sponsor's protocol ID
- 2025-2847
- Acronym
- PIVOT
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07678021
- Acronym / sponsor ID
- PIVOT / 2025-2847
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Left ventricular assist system, complex coronary heart disease, left ventricular dysfunction, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm | Experimental | Device: Microaxial pump-supported PCI, Drug: Optimal medical therapy (OMT)Participants assigned to the intervention arm will undergo PCI supported by the micro-axial flow pump, in addition to optimal medical therapy (OMT). |
| Optimal medical therapy (OMT) alone arm | Other | Drug: Optimal medical therapy (OMT)Participants in this arms will receive guideline-directed optimal medical therapy (OMT) as determined by the heart failure team at each center. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microaxial pump-supported PCIUse CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients | Device | Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm |
| 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. | Drug | Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm, Optimal medical therapy (OMT) alone arm |
Primary outcome
1-year MACCE
Time frame: Up to 1 year after enrollment
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
4 secondary outcomes
Perioperative myocardial infarction
Time frame: Up to 48h after the index PCI procedure
Types 3, 4, and 5 bleeding as defined by MCS-ARC
Time frame: Up to 1 year after enrollment
Severe hemolysis related to the device
Time frame: Up to 72 hours after the implantation of the CorVad left ventricular assist system
Stent thrombosis
Time frame: Up to 1 year after the index PCI procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microaxial pump-supported PCI and Optimal medical therapy (OMT) in people with Coronary Artery Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kefei Dou, MD, PhD (+86-13801032912, drdoukefei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year MACCE (time frame: Up to 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.