Description
Inclusion Criteria:
- * Clinical Inclusion Criteria
- Subjects must meet all of the following clinical criteria to participate in the trial:
- 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
- 2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
- 3. 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.
- 4. 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).
- 5. Subject has life expectancy \> 1 year in the opinion of the investigator.
- 6. Subject is willing and able to provide informed consent and comply with 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:
- 1. 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.
- 2. 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.
- 3. Target lesion is ≤ 36 mm in length.
- 4. Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
- 5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\].
- 6. Target lesion is within a native coronary artery or major branch.
- 7. A target lesion within or near a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.
- 8. The identified target lesion has high probability (\> 70%) for successful treatment with approved pre-treatment techniques and DEB alone.
Exclusion Criteria:
- * Clinical Exclusion Criteria
- Subjects who meet any of the following clinical criteria will be excluded from the trial:
- 1. Subject with known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
- 2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
- 3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
- 4. Subject with planned major surgery within 30 days following the index procedure.
- 5. Subject with planned treatment of lesion involving aorto-ostial location.
- 6. Subject with planned PCI of a non-target vessel within 30 days following the index procedure.
- 7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
- 8. 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).
- 9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
- 10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%.
- 11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
- 12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
- 13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
- * Angiographic Exclusion Criteria
- Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:
- 1. Target lesion is totally occluded or has evidence of thrombus.
- 2. Target lesion is located in the left main or any arterial or venous graft.
- 3. Target lesion is in a side branch that is "jailed" by a main vessel stent.
- 4. In stent restenosis
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No