AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions

Clinical Inclusion Criteria:

• Subject must be at least 18 years of age.

• Subject (or legal guardian) understands the trial requirements and the treatmentprocedures and provides written informed consent before any trial-specific tests orprocedures are performed.

• Subject is eligible for percutaneous coronary intervention (PCI).

• Subject is willing to comply with all protocol-required follow-up evaluation.

• Women of child-bearing potential must agree to use a reliable method ofcontraception from the time of screening through 12 months after the indexprocedure.

Angiographic Inclusion Criteria:

• Target lesion is a de novo lesion located in a native coronary artery

• Target lesion must have visually estimated stenosis > 50% and < 100% in symptomaticsubjects (>70% and <100% in asymptomatic subjects) prior to lesion pre-dilation.

• Target lesion must be successfully pre-dilated.

• If a non-target lesion is treated, it must be treated first and must be deemed asuccess.

Clinical Exclusion Criteria:

• Subject has other serious medical illness (e.g. cancer, congestive heart failure)that may reduce life expectancy to less than 12 months.

• Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin,etc.).

• Subject has planned procedure that may cause non-compliance with the protocol orconfound data interpretation.

• Subject is participating in another investigational drug or device clinical studythat has not reached its primary endpoint.

• Subject intends to participate in another investigational drug or device clinicalstudy within 12 months after the index procedure.

• Subject is a woman who is pregnant or nursing. A pregnancy test must be performedwithin 7 days prior to the index procedure, except for women who definitely do nothave child-bearing potential.

• Subject has left ventricular ejection fraction known to be < 30%.

• Subject had PCI or other coronary interventions within the last 30 days.

• Subject has planned PCI or CABG after the index procedure.

• Subject had STEMI or QWMI <72h prior to the index procedure.

• Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or ishemodynamically unstable.

• Subject has cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluidsupport).

• Subject has history (within 6 months prior to the index procedure) of New York HeartAssociation (NYHA) class III or IV heart failure.

• Subject is considered not able to tolerate at least 30 seconds of coronary occlusionof the target lesion.

• Subject has known allergy to paclitaxel or other components of the used medicaldevices.

• Subject has known hypersensitivity or contraindication to contrast dye that in theopinion of the investigator cannot be adequately pre-medicated.

• Subject has intolerance to antiplatelet drugs, anticoagulants required forprocedure.

• Subject has platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.

• Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysisdependent).

Angiographic Exclusion Criteria:

• In-stent restenosis.

• Target lesion is located within a saphenous vein or arterial graft.

• Target lesion is a total occlusion or has evidence of thrombus present in the targetvessel.

• Target lesion is severely calcified by angiography or has > 270° calcium arc onintravascular imaging or requires atherectomy.

• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)or three-vessel coronary disease requiring revascularization of all 3 vessels.

• Subject with planned treatment of lesion involving aortic ostial location.