DynamX Bioadaptor Hong Kong Registry

Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Inclusion criteria

• Subject age ≥ 18 and ≤ 80 years
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)
• Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
• All lesions requiring PCI should be amendable for implantation with the study stent
• Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being < 35%

Exclusion criteria

• Target lesion / vessel specific

• Lesions in the left main
• Venous or arterial bypass grafts
• In-stent restenosis
• Chronic total occlusion
• Ostial lesions (< 3 mm from the ostium of the RCA, LAD or Cx)
• Stent implanted < 10 mm from the target lesion in the previous 30 days.
• Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification
• Bifurcation lesions requiring a planned 2 or more stent technique
• Patient specific:

• STEMI
• Acute myocardial infarction with Killip Class III and IV
• Known LVEF < 30%
• Life expectancy < 1 year
• Patients on renal dialysis or known GFR < 30 ml/min
• Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months
• Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy)
• Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin)
• Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint
• Known pregnancy or breastfeeding
• Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason