Compares paclitaxel-coated balloons with stents for narrowed heart arteries

Trial details

Who runs it

Translumina GmbH

Trial code

NCT07397845

Record updated

1 June 2026

Original description

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.Read full original descriptionShow less

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

Clinical inclusion criteria:; 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; Angiographic inclusion criteria:; 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); Lesion preparation must be according to the 3rd DCB consensus, with lesions that have:; ≤ 30% residual stenosis; TIMI (Thrombolysis in Myocardial Infarction) flow grade 3; The absence of flow-limiting dissection (Type A-C allowed only); Clinical exclusion criteria:; 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; Angiographic exclusion criteria:; Target lesion is in the left main coronary artery; Target lesion is in a coronary artery bypass graft; Flow limiting target vessel thrombus; Evidence of aneurysm in target vessel within 10 mm of the target lesion; Aorto-ostial target lesion (within 3 mm of the aorta junction).

ClinicalTrials.gov NCT07397845