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

ConditionsCoronary Artery Disease Drug Eluting Balloon Drug Eluting Stent

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTranslumina GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years

Patient with NSTE-ACS or CCS with either symptoms and/or ischemia on non-invasive or invasive testing (i.e. FFR/iFR, CMR, SPECT, PET-CT or stress-echo)

The patient must be able to understand and provide written informed consent and comply with all study procedures

Life expectancy of > 2 years

Disqualifiers

STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI

Pregnancy or nursing declarations (As per country specific guideline) (a negative pregnancy test is required of women with child-bearing potential within 7 days prior to enrollment)

LVEF<30%

Known contraindication or hypersensitivity to any limus family drugs, paclitaxel, or to medications such as heparin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor or any component of the devices.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

1,380 Participants

are divided into 3 treatment groups

Group A: Paclitaxel coated balloonExperimental treatment 1 intervention

Group B: Drug coated balloonActive comparator 1 intervention

Group C: Drug eluting stent (DES)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Device oriented composite endpoint (DOCE)

1. Cardiac death 2. New target vessel - related myocardial infarction (TV-MI) 3. Ischemia-driven target-lesion revascularization (TLR)

Time frame

24 months

Secondary outcomes

Patient oriented composite endpoint (POCE)

1. All-cause death 2. Any Stroke 3. All new MI (TV and non-TV related) 4. Unplanned ischemia-driven repeat revascularization

Time frame

1 month, 6 month, 12 month, 18 month, 24 month

Additional outcomes

Total no of events in 1380 patients will be analysed- 1. Definite or probable vessel (stent) thrombosis 2. Ischemia-driven target-vessel revascularization (TVR) 3. Major bleeding (BARC type 3 to 5)

Time frame

1 month, 6 month, 12 month, 18 month, 24 months

Other outcomes

All individual components of DOCE and POCE

Total no of events in 1380 patients will be analysed - 1. All-cause death 2. Cardiac death 3. Any Stroke 4. All new MI (TV and non-TV related) 5. Ischemia-driven TLR 6. Unplanned ischemia-driven repeat revascularization

Time frame

1 month, 6 month, 12 month, 18 month, 24 month

Other outcomes of interest

Device success: Defined as the ability of the study devices to be delivered, dilated and retrieved from the target lesion during index procedure.

Time frame

0 day (during index PCI)

Other outcomes of interest

Procedure duration, radiation exposure and contrast volume.

Time frame

0 day (during index PCI)

Other outcomes of interest

Procedural success: Achievement of a final diameter stenosis of \< 30% (site-reported) using any PCI method, without the occurrence of death, MI or repeat vessel revascularization during index- hospital stay.

Time frame

7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Translumina GmbH

Lead sponsor

Source ClinicalTrials.gov

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