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

NCT07397845 | Not Yet Recruiting DMC

• 1 other identifier: TL/RCT/DEB/2025-04
• Study Type: interventional
• Target: 1,380
• Locations: 0 countries
• Sites: N/A

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

Keywords

SPARX RCT; Protege

Outcome Measures

Primary Outcomes (1)

• Device oriented composite endpoint (DOCE)

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

  24 months

Secondary Outcomes (2)

• Patient oriented composite endpoint (POCE)

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

• Additional outcomes

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

Other Outcomes (7)

• All individual components of DOCE and POCE

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

• Other outcomes of interest

  0 day (during index PCI)

• Other outcomes of interest

  0 day (during index PCI)

Study Arms (3)

Paclitaxel coated balloon

EXPERIMENTAL

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

Device: Protégé and Protégé NC

Drug coated balloon

ACTIVE COMPARATOR

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

Device: Agent

Drug eluting stent (DES)

ACTIVE COMPARATOR

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

Device: Drug Eluting Stent

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.

Paclitaxel coated balloon

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 coated balloon

Drug Eluting Stent DEVICE

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

Drug eluting stent (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• One or more trial target vessel (LAD, CX or RCA, or of their branches) with:
• Stenosis of ≥70% or
• Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia by positive stress test, or FFR ≤0.80, or iFR \<0.90 or IVUS minimum lumen area ≤4.0 mm2
• The target vessel/target lesion matches at least one of the following criteria
• Small vessel: vessel reference diameter is ≤ 3 mm
• Long lesions: length ≥ 25 mm
• Calcified lesion: grade 3 by angiography or confirmed on intravascular imaging
• Chronic total occlusion (CTO)
• Bifurcation lesions, including ostial LAD and ostial CX
• Lesions in diabetic coronary artery disease
• In-Stent Restenosis (ISR)

You may not qualify if:

• 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.
• Allergy to imaging contrast media which cannot be adequately pre-medicated
• Stroke/TIA during the last 6 months, or any prior intracranial hemorrhage
• Active peptic ulcer or upper gastrointestinal bleeding within last 6 months
• Known renal insufficiency with an eGFR\<30 ml/min1.73m2, or subject on dialysis, or acute renal failure (as per physician judgment)
• Planned surgery within 6 months with the necessity to stop DAPT
• History of bleeding diathesis or coagulopathy
• Platelet count\<100.000 cells/mm3 or \>400.000 cells/mm3, a WBC of \<3000 cells/mm3, documented or suspected liver disease (including laboratory evidence of hepatitis)
• Patient is a recipient of a heart transplant
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
• Target lesion is in the left main coronary artery
• Target lesion is in a coronary artery bypass graft

Sponsors & Collaborators

• Translumina GmbH: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Prof. Dr. Florim Cuculi, MD

  Cardiology Division Heart Center - Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland

  PRINCIPAL INVESTIGATOR

• Prof. Dr. Adnan Kastrati, MD PhD

  German Heart Center Munich Lazarettstraße 36, 80636 München, Germany

  STUDY CHAIR

Central Study Contacts

Dr Brijesh Mishra, PhD

CONTACT

+919654596737; drbrijeshmishra@translumina.in

Deepanshi Thakur, MSc

CONTACT

deepanshithakur@translumina.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, multi-centre, global, open label, clinical trial

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share