Coronary Artery DiseaseNCT05695716
CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
A study testing CSI pVAD System in people with Coronary Artery Disease, run by Abbott Medical Devices at 1 site in Georgia.
Trial summary
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CSI pVAD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGeorgia
- Study dates
- 5 Apr 2023to 17 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years of age
- In the investigator's opinion, the subject is capable of providing informed consent.
- Subject has signed the Independent Ethics Committee (IEC) approved study Informed Consent Form (ICF) prior to any study related procedures
- Subject has a life expectancy ≥1 year
- Subject has a left ventricular ejection fraction (LVEF) ≥15% and ≤40%
- Subject has a planned elective or urgent high risk percutaneous coronary intervention with hemodynamic support
- Subject of child bearing potential has a negative pregnancy test result
Who cannot join
- Subject has ST-Elevation Myocardial Infarction (STEMI) within 30 days prior to study procedure based on criteria in SCAI definition
- Subject has NSTEMI with cardiac enzymes that are not trending downward within 30 days prior to study procedure
- Subject with RV failure (defined as reduced RV function on imaging and evidence of increased CVP >18 mmHg)
- Subject with history of cardiac arrest within 30 days prior to study procedure requiring cardiopulmonary resuscitation OR any history of cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit
- Subject is in cardiogenic shock (defined as systolic BP <90 mmHg, cardiac index <2.1 and/or evidence of impaired end organ perfusion) that is not responsive to fluid infusion or requiring any inotropic or pressor support
- Subject received any pressors or inotropes within 24 hours prior to the start of the study procedure
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- Subject has evidence of current or prior endocarditis
- Subject with active myocarditis
- Subject had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months prior to study procedure
- Subject had a stroke or TIA within 6 months prior to study procedure
- Subject had previous CABG within 6 months prior to study procedure
- Subject had coronary intervention within 30 days prior to study procedure
- Subject has a coronary intervention planned within 30 days post procedure
- Subject has presence of left ventricular (LV) mural thrombus
- Subject has history of valve replacement or repair (e.g., MitraClipTM) including transcatheter edge to edge repair (TEER)
- Subject has significant mitral valve disease (defined as mitral regurgitation greater than moderate, grade ≥2+ by echocardiogram (ECHO), mitral stenosis with MVA <1.5 cm2) or has evidence of structural damage to the chordae tendineae or valve
- Subject has significant aortic valve disease (defined as aortic stenosis (valve area ≤1.5 cm2 or moderate or severe aortic regurgitation (grade ≥2+ by ECHO))
- Subject with atrial fibrillation present at the time of enrollment or any time prior to RHC or CSI pVAD device placement
- Subject has sustained tachycardia with heart rate over 120 BPM
- Subject has sustained ventricular tachycardia either pre- or during intervention
- Subject has severe pulmonary hypertension, defined as mean pulmonary artery pressure ≥40 mmHg
- Subject has presence of an aneurysm or dissection along vascular delivery path including:
- Abdominal aortic aneurysm 4.0 cm or greater, OR
- Significant descending thoracic aortic aneurysm greater than 4.5 cm, OR
- Any dissection of the ascending, transverse, or descending aorta
- Subject has severe peripheral vascular disease that will preclude the use of a 12Fr access sheath, which is required for the insertion of the CSI pVAD catheter
- Subject has severe aortic tortuosity
- Subject has severe aortic calcification that may preclude appropriate placement of the CSI pVAD device
- Subject's vasculature will not tolerate a right heart catheterization (RHC)
- Subject has chronic renal dysfunction defined by either:
- Serum creatinine ≥ 2.5 mg/dl AND/OR
- Requires hemodialysis
- Subject has liver dysfunction with either:
- Elevation of liver enzymes and bilirubin levels to ≥ 3X ULN OR
- Internationalized Normalized Ratio (INR) ≥ 2 OR
- Lactate dehydrogenase (LDH) > 2.5X ULN
- Subject has uncorrectable abnormal coagulation parameters defined as either:
- Platelet count ≤75,000 per μL OR
- INR ≥2.0 or
- Subject has history of heparin induced thrombocytopenia
- Subject has history of bleeding diathesis or known coagulopathy, any recent GU or GI bleed within 30 days prior to study procedure or will refuse blood transfusions
- Subject has anemia (hemoglobin <10.0 g/dL) or polycythemia/hypovolemia (hemoglobin >16.5 g/dL)
- Subject requires, or, in the clinical judgement of the investigators may need, long term support (>6 hours) with a commercially available mechanical circulatory support (MCS) device
- Subject was on any mechanical cardiac support device at any time within 14 days prior to the study procedure.
- Subject has an active systemic infection requiring oral or intravenous antibiotics, or elevated temperature or white blood cell count that may be due to infection
- Subject has been diagnosed with COVID ≤10 days prior to study procedure or is excluded due to COVID based on institution or other (e.g., CDC) guidelines
- Subject has an allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
- Subject has an allergy or intolerance to CSI pVAD System components
- Subject is pregnant
- Subject is currently participating or plans to participate in another investigational drug- or device trial that may affect any of this study's endpoints
- Subject has any other anatomical-, clinical-, social-, etc. characteristics that preclude the subject from being a candidate for the study
- Subject has any contradiction listed in the current IFU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Systems, Inc. (CSI) Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.
- Conditions
- Coronary Artery Disease
- Being tested
- CSI pVAD System
- Keywords
- PCI, pVAD
- 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.
CSI pVAD SystemDevice
The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions.
| Study group | Role | What they receive |
|---|---|---|
| CSI pVAD System | Experimental | clinical use of the CSI pVAD System during high risk percutaneous coronary interventions (HR-PCI) Receives: Device: CSI pVAD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSI pVAD System device placement/procedural success
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Measured: Intraprocedural
Prevention of severe hypotension while on CSI pVAD device support
Percentage of subjects who were free from severe hypotension while on CSI pVAD device support.
Measured: Intraprocedural
Major Device-Related Adverse Events
Percentage of subjects who were free from:
- Access site complications, defined as complications requiring unplanned transfusion of packed red blood cells (1 unit or more) and/or percutaneous or surgical intervention
- Bleeding (BARC category 3 or 5, and category 2 if serious criterion is met)
- Cardiovascular death
- Clinically significant myocardial infarction (MI), classified based on the SCAI and Fourth Universal definitions
- Stroke (ischemic or hemorrhagic), classified based on symptoms on CT or MRI imaging
Measured: from Intraprocedure through study exit at 30 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start5 Apr 2023
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: No subjects enrolled; termination was business decision after acquisition of CSI by Abbott.
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.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, single-site study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Chambers, MD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695716
- Sponsor's protocol ID
- CLN-0017-P
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Systems, Inc. (CSI) Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
- ClinicalTrials.gov ID
- NCT05695716
- Acronym / sponsor ID
- CLN-0017-P
- Conditions
- Coronary Artery Disease
- Keywords
- PCI, pVAD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled; termination was business decision after acquisition of CSI by Abbott.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 25 Jan 2023 (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.
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, single-site study.
| Arm | Type | Receives |
|---|---|---|
| CSI pVAD System | Experimental | Device: CSI pVAD Systemclinical use of the CSI pVAD System during high risk percutaneous coronary interventions (HR-PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is ≥18 years of age
- In the investigator's opinion, the subject is capable of providing informed consent.
- Subject has signed the Independent Ethics Committee (IEC) approved study Informed Consent Form (ICF) prior to any study related procedures
- Subject has a life expectancy ≥1 year
- Subject has a left ventricular ejection fraction (LVEF) ≥15% and ≤40%
Key exclusion criteria (52 listed)
- Subject has ST-Elevation Myocardial Infarction (STEMI) within 30 days prior to study procedure based on criteria in SCAI definition
- Subject has NSTEMI with cardiac enzymes that are not trending downward within 30 days prior to study procedure
- Subject with RV failure (defined as reduced RV function on imaging and evidence of increased CVP >18 mmHg)
- Subject with history of cardiac arrest within 30 days prior to study procedure requiring cardiopulmonary resuscitation OR any history of cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit
- Subject is in cardiogenic shock (defined as systolic BP <90 mmHg, cardiac index <2.1 and/or evidence of impaired end organ perfusion) that is not responsive to fluid infusion or requiring any inotropic or pressor support
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 |
|---|---|---|
| CSI pVAD SystemThe CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions. | Device | CSI pVAD System |
Primary outcome
CSI pVAD System device placement/procedural success
Time frame: Intraprocedural
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Prevention of severe hypotension while on CSI pVAD device support
Time frame: Intraprocedural
Percentage of subjects who were free from severe hypotension while on CSI pVAD device support.
Major Device-Related Adverse Events
Time frame: from Intraprocedure through study exit at 30 day follow up
Percentage of subjects who were free from: * Access site complications, defined as complications requiring unplanned transfusion of packed red blood cells (1 unit or more) and/or percutaneous or surgical intervention * Bleeding (BARC category 3 or 5, and category 2 if serious criterion is met) * Cardiovascular death * Clinically significant myocardial infarction (MI), classified based on the SCAI and Fourth Universal definitions * Stroke (ischemic or hemorrhagic), classified based on symptoms on CT or MRI imaging
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Jeff Chambers, MD study director
Abbott Medical Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSI pVAD System in people with Coronary Artery Disease, run by Abbott Medical Devices at 1 site in Georgia.
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 7 inclusion and 52 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: withdrawn, as of the sponsor's last update on 17 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 1 site in Georgia. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSI pVAD System device placement/procedural success (time frame: Intraprocedural). The study lists 3 primary outcomes in all. 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 17 Jan 2024.