United States, Belgium, Brazil418 participantsStarted 2020-07-06
Plain-language summary
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR 014 DEB in all patients.
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
. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
. Subject presents with chronic coronary syndrome (CCS) (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST-elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for percutaneous coronary intervention (PCI) and planned intervention.
. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
. Life expectancy \>1 year in opinion of investigator.
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.
. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
. Target lesion is within a native coronary artery or major branch.
. Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
Exclusion criteria
. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
. ST-elevation myocardial infarction (STEMI) within 30 days.
. Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
. Target lesion is located within a bifurcation with planned treatment of side branch vessel.
. Target lesion is the 3rd or greater stent failure (i.e., more than two \[2\] layers of stent are present at any segment of the target lesion).
. Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
. Previous PCI of the target vessel within 30 days.
. Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.