Coronary Artery DiseaseNCT05315544
Cardiovascular Systems Inc. (CSI) pVAD First 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
This study will collect initial clinical data on the CSI pVAD system 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
- 5 participants
- Where
- 1 siteGeorgia
- Study dates
- 14 Mar 2022to 16 Mar 2022
- 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
- Male or non- pregnant female ≥ 18 years of age
- Life expectancy ≥ 1 year
- Ejection Fraction (EF) >15% and ≤ 40%
- Scheduled for an elective high risk percutaneous coronary intervention
Who cannot join
- Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
- Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
- Cardiogenic shock
- Left ventricular (LV) mural thrombus
- Presence of a prosthetic valve or a heart constrictive device
- Aortic stenosis
Show all 23Show fewer
- Moderate or severe aortic regurgitation (≥ 2+ by echo)
- Severe peripheral vascular disease that will preclude the use of a 12F access sheath, which is required for the insertion of the CSI pVAD catheter
- Severe aortic tortuosity
- Severe aortic calcification
- Vasculature will not tolerate a right heart catheterization
- Renal dysfunction (serum creatinine ≥ 2.5 mg/dl) or requirement for hemodialysis
- Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X upper lab normal (ULN) or Internationalized Normalized Ratio (INR) ≥ 2 or lactate dehydrogenase (LDH) > 2.5X ULN
- Uncorrectable abnormal coagulation parameters
- History of heparin induced thrombocytopenia
- Sustained ventricular tachycardia
- Stroke or transient ischemic attack (TIA) within 6 months or any permanent neurological deficit
- Chronic anemia (hemoglobin < 8 g/dL)
- Subject may require long term support with a commercially available hemodynamic support device
- Active systemic infection requiring oral or intravenous antibiotics
- Allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
- Allergy or intolerance to system components
- Participation in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
- Conditions
- Coronary Artery Disease
- Being tested
- CSI pVAD system
- Keywords
- pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)
- 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 | Experimental | Not described Receives: Device: CSI pVAD system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Measured: Intraprocedural
Intraprocedural Major Device-Related Adverse Events
Composite incidence of:
- Cardiovascular death
- Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions
- Any repeat revascularization (PCI or CABG)
- Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Measured: 24-hours Post-Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start14 Mar 2022
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
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
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT05315544
- Sponsor's protocol ID
- CLN-0015-P
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2022
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
- ClinicalTrials.gov ID
- NCT05315544
- Acronym / sponsor ID
- CLN-0015-P
- Conditions
- Coronary Artery Disease
- Keywords
- pVAD, High risk PCI, Cardiovascular Systems, Inc., Mechanical Circulatory Support (MCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 7 Apr 2022 (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 will collect initial clinical data on the CSI pVAD system 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
| Arm | Type | Receives |
|---|---|---|
| CSI pVAD | Experimental | Device: CSI pVAD system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non- pregnant female ≥ 18 years of age
- Life expectancy ≥ 1 year
- Ejection Fraction (EF) >15% and ≤ 40%
- Scheduled for an elective high risk percutaneous coronary intervention
Key exclusion criteria (23 listed)
- Hemodynamically unstable MI with elevated cardiac biomarker and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from a previous value OR ST-Elevation Myocardial Infarction (STEMI) within 14 days of Index Procedure
- Pre-Procedure cardiac arrest within 24 hours of enrollment requiring cardiopulmonary resuscitation
- Cardiogenic shock
- Left ventricular (LV) mural thrombus
- Presence of a prosthetic valve or a heart constrictive 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 |
|---|---|---|
| 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 |
Primary outcome
Procedural success
Time frame: Intraprocedural
Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system
Intraprocedural Major Device-Related Adverse Events
Time frame: 24-hours Post-Index Procedure
Composite incidence of: * Cardiovascular death * Clinically significant myocardial infarction (MI) defined as the composite of MI events per Society for Cardiovascular Angiography and Intervention (SCAI) periprocedural MI and Fourth Universal MI definitions * Any repeat revascularization (PCI or CABG) * Stroke defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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 4 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: finished, as of the sponsor's last update on 11 Dec 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procedural success (time frame: Intraprocedural). The study lists 2 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 11 Dec 2023.