Paclitaxel-coated balloons compared to drug-eluting stents in the treatment of narrowed blood vessels of the heart
Summary description of the study
The SPARX STUDY was designed for patients suffering from ischemic heart disease – a condition where there is an imbalance between the oxygen supply and demand of the heart muscle. The two subtypes of this disease are the focus of this study: chronic coronary syndromes (CCS) and acute coronary syndrome without ST-segment elevation (NST-ACS). The aim is to compare different medical devices routinely used in hospitals for the treatment of patients with CCS and NST-ACS. The SPARX study was developed to compare two DCBs (Protégé™ and Agent™) with standard DES in complex and small coronary lesions. The idea behind it is that paclitaxel-coated balloons work as well as modern drug-eluting stents. The study also compares Protégé and Agent, two well-known drug-eluting balloons. The main hypothesis states that Protégé™ works at least as well as Agent™. In this study, participants are randomly assigned to three groups. This is called randomization. Each group receives treatment with a different medical product - drug-eluting stents or the drug-eluting balloon Protégé or the drug-eluting balloon Agent. Regardless of which group patients are assigned to, they receive a standard treatment that is also applied to all other patients with the same condition. SPRAX is a so-called open study. This means that both the doctor and the patient know which group they have been assigned to and which treatment they have received. A total of 1380 patients are expected to participate in this clinical study across approximately 30 hospitals in several countries such as Switzerland, Germany, France, Italy, Austria, the Netherlands, and India. Each patient's participation in this clinical study is expected to last up to 24 months.
(BASEC)
Intervention under investigation
The intervention being studied is a percutaneous coronary intervention (PCI), where either balloon angioplasty is performed with a drug-eluting balloon that delivers and releases a drug evenly to the vessel wall, or a drug-eluting stent (DES) is implanted. Regardless of which group patients are assigned to, they receive a standard treatment that is also applied to all other patients with the same condition.
(BASEC)
Disease under investigation
The disease under investigation is ischemic heart disease – a condition where there is an imbalance between the oxygen supply and demand of the heart muscle. The two subtypes of this disease are the focus of this study: chronic coronary syndromes (CCS) and acute coronary syndrome without ST-segment elevation (NST-ACS).
(BASEC)
1. Age ≥18 years 2. Patients with NSTE-ACS or CCS with either symptoms and/or ischemia on non-invasive or invasive tests (i.e., FFR/iFR, CMR, SPECT, PET-CT, or stress echo) 3. The patient must be able to understand and provide written informed consent and comply with all study procedures (BASEC)
Exclusion criteria
1. STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI 2. Pregnancy or breastfeeding certificate (according to country-specific guidelines) (a negative pregnancy test is required within 7 days prior to enrollment for women of childbearing age) 3. LVEF<30% (BASEC)
Trial sites
Luzern
(BASEC)
Sponsor
Sponsor: Blue Medical Devices B.V., A Translumina Group Company Swiss Representative: Effectum Medical
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Matthias Bossard
+41 412051477
matthias.bossard@clutterluks.chLuzerner Kantonsspital - Heart Center
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
07.04.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Stents versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available