Coronary Artery DiseaseNCT06198998
CorVad Percutaneous Ventricular Assist System Study
A study testing CorVad Percutaneous Ventricular Assist System in people with Coronary Artery Disease, run by Shenzhen Core Medical Technology CO.,LTD. at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CorVad Percutaneous Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesChina
- Study dates
- 19 Oct 2023to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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:
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- Unprotected left main intervention;
- 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.
Who cannot join
- 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:
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Ke Fei Dou, drdoukefei@126.com
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410002
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
- Not yet recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
- Recruiting
Shanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, 200120
- Not yet recruiting
Tangdu Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
- Not yet recruiting
Xijing Hospital of Air Force Military Medical University
Xi’an, Shanxi, 710032
About this study
Official title: The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System
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.
Read the detailed description
This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects.
The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- CorVad Percutaneous Ventricular Assist System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorVad Percutaneous Ventricular Assist SystemDevice
The CorVad Percutaneous Ventricular Assist System provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CorVad Percutaneous Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 30 days post-PCI
Secondary outcomes (7)
Hemodynamic stability during PCI procedure
Defined as mean arterial pressure (MAP) <60mmHg for no more than 10 minutes during the PCI procedure, without needing additional pharmacological therapy.
Measured: During PCI procedure
PCI procedural angiographic success rate
Angiographic success defined as: residual stenosis <30% post stent implantation or residual stenosis <50% post balloon angioplasty. Success rate calculated based on number of treated lesions.
Measured: Post-PCI
Change of aortic valve regurgitation
Defined as changing from no or mild aortic regurgitation pre-procedure to moderate or severe regurgitation on pre-discharge echocardiography.
Measured: Pre-procedure and pre-discharge
Change in creatinine clearance at 48 hours post-PCI
Assessed at 48 hours post-PCI and compared to baseline.
Measured: Pre-procedure and 48 hours post-PCI
Change in left ventricular ejection fraction (LVEF) pre- and post-PCI
Assessed at 48 hours post-PCI and pre-discharge, and compared to baseline.
Measured: Pre-procedure, 48 hours post-PCI and pre-discharge
Change in New York Heart Association (NYHA) functional classification
Evaluated based on NYHA classification and compared to baseline.
Measured: Pre-procedure and post-PCI
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.
Major adverse events were defined as follows: death, new myocardial infarction, stroke, and target vessel revascularisation.
Calculation formula:
90-day MACCE rate = Number of subjects experiencing any MACCE event within 90 days post-PCI ÷ Total number of subjects × 100%
Measured: 90 days post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start19 Oct 2023
- Primary completion18 Oct 2024 (estimated)
- Study completion18 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ke Fei Dou, Principal investigator, Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198998
- Sponsor's protocol ID
- COREMED_Corvad_HRPCI
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At this moment the IPD is not yet available for access and will be updated when it is ready.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System
- ClinicalTrials.gov ID
- NCT06198998
- Acronym / sponsor ID
- COREMED_Corvad_HRPCI
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 18 Oct 2024 (estimated)
- Study completion
- 18 Oct 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
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.
Detailed description
This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects.
The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorVad Percutaneous Ventricular Assist System | Experimental | Device: CorVad Percutaneous Ventricular Assist SystemSubjects with coronary artery disease receiving high-risk PCI will be supported by the CorVad Percutaneous Ventricular Assist System during the procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (23 listed)
- 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:
- 4. Presence of left ventricular thrombus;
- 5. Presence of mechanical aortic valve or cardiac contractility device;
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 |
|---|---|---|
| CorVad Percutaneous Ventricular Assist SystemThe CorVad Percutaneous Ventricular Assist System provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention. | Device | CorVad Percutaneous Ventricular Assist System |
Primary outcome
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
Time frame: 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%
7 secondary outcomes
Hemodynamic stability during PCI procedure
Time frame: During PCI procedure
PCI procedural angiographic success rate
Time frame: Post-PCI
Change of aortic valve regurgitation
Time frame: Pre-procedure and pre-discharge
Change in creatinine clearance at 48 hours post-PCI
Time frame: Pre-procedure and 48 hours post-PCI
Change in left ventricular ejection fraction (LVEF) pre- and post-PCI
Time frame: Pre-procedure, 48 hours post-PCI and pre-discharge
Change in New York Heart Association (NYHA) functional classification
Time frame: Pre-procedure and post-PCI
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.
Time frame: 90 days post-PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Yes. At this moment the IPD is not yet available for access and will be updated when it is ready.
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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. This study is not recruiting at the moment.
Ke Fei Dou principal investigator
Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorVad Percutaneous Ventricular Assist System in people with Coronary Artery Disease, run by Shenzhen Core Medical Technology CO.,LTD. at 12 sites 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Shi (+86 13418601356, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI. (time frame: 30 days post-PCI). 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 10 Jan 2024.