BridgeMD
New treatment option for Coronary Artery Disease
Official title Prevail Global Study
ClinicalTrials.gov ID: NCT06535854
What this study is testing
- What it's testing
- The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- 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 and older
You may be able to join if
- ≥ 18 years
- Negative pregnancy test
- Stable or unstable angina, positive functional test, or stable NSTEMI
- Life expectancy \>1 year
- Willing and able to cooperate with study procedures and required follow up evaluations
You likely can't join if
- Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
- Platelet count \ 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
- Renal insufficiency (or failure)
- Acute MI
- Previous PCI of the target vessel within 6 months prior to the procedure
See the full eligibility criteria
- ≥ 18 years
- Negative pregnancy test
- Stable or unstable angina, positive functional test, or stable NSTEMI
- Life expectancy \>1 year
- Willing and able to cooperate with study procedures and required follow up evaluations
- Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
- Platelet count \ 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
- Renal insufficiency (or failure)
- Acute MI
- Previous PCI of the target vessel within 6 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
- History of a stroke or transient ischemic attack (TIA)
- Active peptic ulcer or upper gastrointestinal (GI) bleeding
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Documented left ventricular ejection fraction (LVEF) \<30%
- Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Stanford, California, United States
- Loveland, Colorado, United States
- Washington D.C., District of Columbia, United States
- Clearwater, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Naperville, Illinois, United States
- Fort Wayne, Indiana, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Wichita, Kansas, United States
- Edgewood, Kentucky, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Stanford, California, United States; Loveland, Colorado, United States and 42 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.