SELUTION 4 De Novo Small Vessel IDE Trial

Prior treatment

• Subject with planned major surgery within 30 days following the index procedure.
• Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
• Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
• Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.
• The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
• Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.
• Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.
  • Angiographic Exclusion Criteria
  • Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:

Other illness

• Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
• Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
• Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
• Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.

Lab values

• Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
• Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation.
  • PK Sub-Study Exclusion Criteria:
  • Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:

Other

• Clinical Exclusion Criteria
  • Subjects who meet any of the following clinical criteria will be excluded from the trial:
• Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
• Subject with planned treatment of lesion involving aorto-ostial location.
• Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
• Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
• Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
• Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.
• Subject is concurrently enrolled in the main protocol angiographic registry.
• Target lesion is totally occluded or has evidence of thrombus.
• Target lesion is located in the left main or any arterial or venous graft.
• Target lesion is in a side branch that is "jailed" by a main vessel stent.
• In stent restenosis

• Clinical Inclusion Criteria
  • Subjects must meet all of the following clinical criteria to participate in the trial:
• Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
• Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
• Subject presents with chronic coronary syndromes \[CCS\] (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 PCI and planned intervention.
• Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
• Subject has life expectancy \> 1 year in the opinion of the investigator.
• Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  • PK Sub- Study Inclusion Criteria:
  • Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:
  • 1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.
  • Imaging Inclusion Criteria
  • Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:
• A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \> 30 days from the index procedure.
• Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.
• Target lesion is ≤ 36 mm in length.
• Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
• Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\].
• Target lesion is within a native coronary artery or major branch.
• A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.
• The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.