Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTranslumina GmbH
About this trial
The main objective of the SPARX trial is to compare paclitaxel-coated balloons to with contemporary DES in complex and small coronary artery lesions in patients with NSTEACS or CCS; the co-primary objective is to compare two different paclitaxel-coated balloons, Protégé and Agent, with each other.
Eligibility criteria
Qualifiers
Age≥18 years
Patient with NSTE-ACS or CCS with either symptoms and/or ischemia on non-invasive or invasive testing (i.e. FFR/iFR, CMR, SPECT, PET-CT or stress-echo)
The patient must be able to understand and provide written informed consent and comply with all study procedures
Life expectancy of > 2 years
Disqualifiers
STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI
Pregnancy or nursing declarations (As per country specific guideline) (a negative pregnancy test is required of women with child-bearing potential within 7 days prior to enrollment)
LVEF<30%
Known contraindication or hypersensitivity to any limus family drugs, paclitaxel, or to medications such as heparin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor or any component of the devices.
Trial design
Treatments tested in this trial
- Protégé and Protégé NC
- Agent
- Drug Eluting Stent
Treatment groups
1,380 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov