SELUTION SLR™ 014 In-stent Restenosis (SELUTION4ISR)
Coronary Restenosis
About this trial
This is an interventional treatment trial for Coronary Restenosis focused on measuring In-stent restenosis, Drug Eluting Balloon, Coronary
Eligibility Criteria
Clinical 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.
- Documented stable or unstable angina including non-ST-elevation MI or functional testing demonstrating ischemia.
- Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either, Clopidogrel, Prasugrel, or Ticagrelor.
- Life expectancy >1 year in opinion of investigator.
- Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
Angiographic Inclusion Criteria
- Target lesion is within a previously placed BMS or DES and does not extend > 5.00 mm beyond proximal or distal edge.
- Target lesion is < 36 mm in length.
- Target lesion has diameter stenosis of > 50% and < 100% with distal flow at least Thrombolysis in Myocardial Infarction (TIMI) 2.
- RVD is ≥ 2.00 mm and ≤ 4.50 mm.
- Target lesion is within a native coronary artery or major branch.
- Up to two (2) non-target lesions in non-target vessels may be treated, but successful percutaneous coronary Intervention (PCI) must be completed before treatment of target lesion.
Clinical 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 target vessel or > two (2) non-target lesions within non-target vessels during index procedure.
- Planned treatment of lesion involving bifurcation or aorto-ostial location.
- Target lesion has undergone > two (2) prior stent implant procedures (including the initial index procedure, i.e., > two (2) layers of stent are present at any segment of target lesion).
- Any previous brachytherapy of the target vessel.
- Previous PCI of the target vessel within 30 days.
- Planned PCI of a non-target vessel within 30 days of randomization.
- Planned use of atherectomy (rotational, orbital, or laser) device. Use of cutting or scoring balloon is allowed.
- History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
- Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
- Documented left ventricular ejection fraction (LVEF) < 25%.
- Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
Angiographic Exclusion Criteria
- Target lesion is totally occluded or has evidence of thrombus.
- Target lesion is severely calcified, defined as visual calcification involving both walls of the target segment as seen on a non-contrast still image.
- Stent diameter <80% of RVD after high pressure stent expansion.
- >30% residual stenosis after pre-dilation.
Sites / Locations
- HartCentrum Hasselt, Jessa ZiekenhuisRecruiting
- Hôpital privé Jaques CartierRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SELUTION SLR™ DEB
Control Treatment
For subjects randomized to the control group (SOC) the treating physician may chose to implant a commercially available DES or alternatively may use POBA only to treat the patient. The decision should be based on the treating physicians' assessment of the best treatment option for the individual patient. However, it is expected that patients with one prior stent will receive DES and patients with two prior stents will receive POBA. Treating physicians may deviate from this if it is determined to be in the best interest of the patient, but the justification for the treatment decision must be recorded in eCRF. Choice of DES is at the treating physician's discretion, but is limited to ZES and EES devices.