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

Sponsor
Translumina GmbH
Study ID
NCT07397845
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Protégé and Protégé NC — DEVICE
    Protégé Drug-eluting PTCA Balloon Catheters are rapid exchange catheters with a semi-compliant (Protégé DEB) balloon, or a non-compliant (NC) balloon (Protégé NC DEB), both with paclitaxel coating. Protégé is certified and CE marked.
  • Agent — DEVICE
    The AgentTM Paclitaxel-Coated Balloon Catheter (AgentTM DCB) is a monorail, semi-compliant PCI catheter. Agent™ PCB is CE and FDA certified and approved for clinical use both in Europe and in the US.
  • Drug Eluting Stent — DEVICE
    Drug Eluting stents is a standard of care treatment for narrowed coronary arteries of the patients

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Apr 22, 2026
Status verified
Oct 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
1,380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Paclitaxel coated balloon
    Patients are only randomized after successful lesion preparations performed as per the the 3rd DCB Consensus. Post this, if the automatic generation of the device reflects Protege on the opted platform, then the patient is enrolled in this arm of the RCT
  • Active Comparator: Drug coated balloon
    Patients are only randomized after successful lesion preparations performed as per the the 3rd DCB Consensus. Post this, if the automatic generation of the device reflects Agent on the opted platform, then the patient is enrolled in this arm of the RCT
  • Active Comparator: Drug eluting stent (DES)
    DES to standard of care treatment during percutaneous coronary intervention. In this RCT, patients are only randomized after successful lesion preparations performed as per the the 3rd DCB Consensus. Post this, if the automatic generation of the device reflects DES (CE/FDA marked) on the opted platform, then the patient is enrolled in this arm of the RCT

Primary Outcome Measure

Device oriented composite endpoint (DOCE) [ Time Frame: 24 months ]

Central Contacts

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