High-risk Percutaneous Coronary InterventionVITALYST EFSNCT06132568
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
A study testing VITALYST System in people with High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary, run by Boston Scientific Corporation at 5 sites in 2 countries.
Trial summary
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary
- What is being tested?
- VITALYST System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 9 May 2024to 17 Jan 2025
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provides signed informed consent.
- Subject is ≥ 18 years and < 90 years of age.
- Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories)
- Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.
Who cannot join
- Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes.
- Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment.
- Subject has systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine < 30 mL/hour).
- Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg.
- Subject has left ventricular mural thrombus.
- Subject has a prosthetic aortic valve.
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- Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).
- Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as > 2+).
- Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.
- Subject has PVD preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the IFU.
- Subject is not on dialysis and has creatinine > 4 mg/dL.
- Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin > 3× ULN or INR ≥ 2.
- Subject has had a recent (within 30 days) stroke or TIA.
- Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol.
- Subject has current or a history of heparin induced thrombocytopenia.
- Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0.
- Subject has significant right heart failure based on any one of the following criteria: RVSWI < 0.30 mmHg·L/m² or PVR > 3.6 Woods units or Pulmonary artery pulsatility index < 1.85
- Subject requires non-elective mechanical ventilation.
- Subject has an atrial or ventricular septal defect (including post-infarct VSD).
- Subject has left ventricular rupture.
- Subject has cardiac tamponade.
- Subject has severe pulmonary disease (FEV1 < 1L).
- Subject has sustained or non-sustained ventricular tachycardia.
- Subject is breast feeding or is pregnant.
- Subject has infection of the proposed procedural access site or active systemic infection.
- Subject has any condition that requires premature discontinuation of recommended antiplatelet and/or anticoagulant therapy before 90 days following the index procedure.
- Any use of a mechanical circulatory support device within 14 days prior to the index procedure.
- Staged PCI is planned within 90 days following device removal.
- Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
- Subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival)
- Subject has other disease condition(s) which the Investigator has determined may cause non-compliance to the study requirements.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
About this study
Official title: VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
Read the detailed description
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System.
The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
- Being tested
- VITALYST System
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITALYST SystemDevice
Also called Percutaneous Mechanical Circulatory Support
The VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| High Risk PCI Patients | Experimental | Patients undergoing non-emergent, high-risk percutaneous coronary interventions Receives: Device: VITALYST System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
The primary endpoint consists of the composite endpoint of Clinical Success [measured through 72 hours or hospital discharge (whichever comes first)], which is defined as follows.
- Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system
- Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes
- No conversion to open heart surgery
- No mortality
Measured: Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 May 2024
- Primary completion24 Oct 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132568
- Sponsor's protocol ID
- S2496
- Acronym
- VITALYST EFS
- Status last verified
- Jun 2025
- First submitted
- 7 Nov 2023
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06132568
- Acronym / sponsor ID
- VITALYST EFS / S2496
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 15 Nov 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 VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
Detailed description
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System.
The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Risk PCI Patients | Experimental | Device: VITALYST SystemPatients undergoing non-emergent, high-risk percutaneous coronary interventions |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject provides signed informed consent.
- Subject is ≥ 18 years and < 90 years of age.
- Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories)
- Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.
Key exclusion criteria (31 listed)
- Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes.
- Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment.
- Subject has systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine < 30 mL/hour).
- Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg.
- Subject has left ventricular mural thrombus.
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 |
|---|---|---|
| VITALYST SystemAlso: Percutaneous Mechanical Circulatory SupportThe VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease. | Device | High Risk PCI Patients |
Primary outcome
Clinical Success
Time frame: Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure
The primary endpoint consists of the composite endpoint of Clinical Success [measured through 72 hours or hospital discharge (whichever comes first)], which is defined as follows. * Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system * Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes * No conversion to open heart surgery * No mortality
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 22 Jun 2025.
- Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITALYST System in people with High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary, run by Boston Scientific Corporation at 5 sites in 2 countries.
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 31 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Sweden. 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?
Clinical Success (time frame: Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure). 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 22 Jun 2025.