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New treatment option for High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Official title ELEVATE High-Risk PCI Pivotal Study
ClinicalTrials.gov ID: NCT07001332
What this study is testing
- What it's testing
- The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 88
You may be able to join if
- Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or...
- A heart team that includes an treatment cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
- Participant signed the informed consent.
You likely can't join if
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
- Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
- Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index...
- Evidence of left ventricular thrombus.
- Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
- ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
See the full eligibility criteria
- Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
- A heart team that includes an treatment cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
- Participant signed the informed consent.
- Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
- Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
- Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
- Evidence of left ventricular thrombus.
- Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
- ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
- Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
- Patient on dialysis.
- Known or suspected coagulopathy OR abnormal coagulation parameters.
- Known allergy, sensitivity or intolerance to nickel.
- Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
- Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
- Any non-cardiac condition with a life expectancy \< 12 months.
- Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
- Pregnancy or breast-feeding.
- Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
- Subject belongs to a vulnerable population.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Edgewood, Kentucky, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Morristown, New Jersey, United States
- New Brunswick, New Jersey, United States
- Brooklyn, New York, United States
- Buffalo, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
+ 6 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; La Jolla, California, United States; San Francisco, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.