Scoreflex TRIO - Scoring PTCA Catheter

This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 210 subjects. All subjects enrolled will be randomly assigned to the test group (n=105) and the control group (n=105). Subjects in the test group and the control group will receive Scoreflex TRIO Scoring PTCA catheters and Scoreflex NC Scoring PTCA catheters respectively.

Inclusion criteria

• Age ≥ 18 and≤ 80.
• Volunteer to participate in this trial and provide the written informed consent.
• Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia, need percutaneous coronary intervention.

Angiographic Inclusion Criteria

• Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
• A maximum of two lesions that needed to be treated and they are located in two coronary arteries, including at least one target lesion, in up to two coronary arteries.
• Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
• Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation.
• The non-target lesion must be located in different coronary artery from the Target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.

Exclusion criteria

• STEMI or NSTEMI within 7 days of study screening.
• A serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
• Cerebrovascular accident (CVA) within the past 6 months.
• Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
• Left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary)
• Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications,
• Subject is known to be allergic to the ingredients of the test product and the sensitivity to contrast media.
• Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
• Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
• Subjects who are participating in clinical research of other drugs and devices.
• Other conditions assessed by the investigator as inappropriate to participate in this trial.

Angiographic Exclusion Criteria

• Target lesion longer than 30 mm by visual estimation.
• Extreme angulation (90º or greater) proximal to or within the target lesion.
• Target lesion located within an arterial or saphenous vein graft or graft anastomosis
• Previous percutaneous intervention of lesions in a target vessel (including side branches) conducted within 9 months before the study procedure and located within 10 mm from the current target lesion.
• Target lesion demonstrating severe dissection prior to planned deployment of the investigational device.
• Unprotected left main coronary artery disease.
• Coronary artery spasm of the target vessel in the absence of a significant stenosis.
• Target lesion with angiographic presence of probable or definite thrombus.
• Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.
• Non-target lesion to be treated during the index procedure meets any of the following criteria:

• Located within a bypass graft (venous or arterial)
• Left main location
• Chronic total occlusion
• Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
• Treatment not deemed a clinical angiographic success