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

AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease

AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions.

Subjects must have a de novo target lesion located in a native coronary artery.

The study will also contain a PK sub study and an IVUS sub study.

Clinical Inclusion Criteria:

• Subject must be at least 18 years of age.
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures 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 of contraception from the time of screening through 12 months after the index procedure.

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 symptomatic subjects (>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 a success.

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 or confound data interpretation.
• Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
• Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
• Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have 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 is hemodynamically unstable.
• Subject has cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support).
• Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
• Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.
• Subject has known allergy to paclitaxel or other components of the used medical devices.
• Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
• Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.
• Subject has platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.
• Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).

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 target vessel.
• Target lesion is severely calcified by angiography or has > 270° calcium arc on intravascular 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.