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

NCT07397845 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1380

Last updated 2026-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Translumina GmbH

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Florim Cuculi, MD · Cardiology Division Heart Center - Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland

  • Prof. Dr. Adnan Kastrati, MD PhD · German Heart Center Munich Lazarettstraße 36, 80636 München, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-04-30
Completion
2029-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07397845 on ClinicalTrials.gov