Paclitaxel-coated balloons compared to drug-eluting stents in the treatment of narrowed blood vessels of the heart

Zusammenfassung der Studie

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)

Untersuchte Intervention

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)

Untersuchte Krankheit(en)

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)

Sponsor

Sponsor: Blue Medical Devices B.V., A Translumina Group Company Swiss Representative: Effectum Medical

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

(BASEC)

Datum der Bewilligung durch die Ethikkommission

07.04.2026

(BASEC)

Ergebnisse der Studie