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NOT YET RECRUITING
NCT07397845
NA

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

Sponsor: Translumina GmbH

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1380

Start Date

2026-03

Completion Date

2029-04

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DEVICE

Protégé and Protégé NC

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.

DEVICE

Agent

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.

DEVICE

Drug Eluting Stent

Drug Eluting stents is a standard of care treatment for narrowed coronary arteries of the patients