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Studies

Interventional Recruiting

NCT07397845 on ClinicalTrials.gov

Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial

  • Sponsor: Translumina GmbH
  • Enrollment: 1380 (Estimated)
  • Study start: 2026-04-22 (Actual)
  • Primary completion: 2028-04-01 (Estimated)
  • Study completion: 2029-04-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Randomized, controlled, multi-centre, global, open label, clinical trial
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Coronary Artery Disease
  • Drug Eluting Balloon
  • Drug Eluting Stent

Intervention / Treatment

  • Device: Protégé and Protégé NC
  • Device: Agent
  • Device: Drug Eluting Stent

Primary Outcome Measures

  • Device oriented composite endpoint (DOCE) (24 months)
    1. Cardiac death 2. New target vessel - related myocardial infarction (TV-MI) 3. Ischemia-driven target-lesion revascularization (TLR)

Countries

Switzerland

Locations and Investigators

  • Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland, Lucerne, Switzerland (Recruiting)
    • Monika Röthlin

Study Officials

  • Prof. Dr. Florim Cuculi, MD (Principal Investigator) — Cardiology Division Heart Center - Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland
  • Prof. Dr. Adnan Kastrati, MD PhD (Study Chair) — German Heart Center Munich Lazarettstraße 36, 80636 München, Germany