Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vess… (NCT07397845) | Clinical Trial Compass
RecruitingNot Applicable
Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial
Switzerland1,380 participantsStarted 2026-04-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The target vessel/target lesion matches at least one of the following criteria
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)