Prevail Global Study
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Vascular
About this trial
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Eligibility criteria
Qualifiers
≥ 18 years
Negative pregnancy test
Stable or unstable angina, positive functional test, or stable NSTEMI
Life expectancy >1 year
Disqualifiers
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 < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
Renal insufficiency (or failure)
Trial design
Treatments tested in this trial
- Prevail DCB
- Agent DCB
Treatment groups
1,205 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov