infinity-swedeheart registry based randomized clinical trial (r-rct)

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: the infinity-swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. eligible patients will be randomized 1:1 (dynamx bioadaptor : resolute onyx).

the infinity-swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. eligible patients will be randomized 1:1 (dynamx bioadaptor : resolute onyx). 2400 patients will be randomized in sweden. patients will be followed at 30 days and 1 year by phone, and at 6 months and 2 to 5 years through clinical and diagnostic registries.

Eligibility criteria:
general inclusion criteria: * patient age ≥ 18 and ≤ 85 years * patient understands the trial requirements and treatment procedures and provides informed consent prior to any trial-specific tests or treatment * patients with ccs (stable angina, chronic angina, and chronic coronary artery disease) or acs (unstable angina, st-elevated myocardial infarction, and non-st-elevated myocardial infarction) indicated for a percutaneous intervention with stent implantation. angiographic inclusion criteria: * patient has ≤ 3 lesions planned to be treated during the index procedure, each in a native epicardial vessel (including up to 1 planned non-target lesion). 1. treatment is limited to a maximum of 2 target lesions per epicardial vessel. any planned non-target lesion must be located in a separate vessel from target lesion(s). 2. when treatment of 2 target lesions in a single epicardial vessel is planned, there must be adequate separation between lesions to ensure a gap of greater than or equal to 10 mm between study devices. 3. if a planned non-target lesion is present it must have been treated without complication\* prior to randomization. 4. the definition of epicardial vessels is the lad, lcx and rca, and is inclusive of their branches. * target lesion vessel diameter(s) and lesion length(s) suitable for implantation with either study device (dynamx bioadaptor or control) using a single device per lesion. * successful pre-dilatation of a minimum of 1 target lesion, defined as no waist in the inflated pre-dilatation balloon (using two orthogonal views) with a pre-dilatation balloon diameter size approximately 0.25 mm smaller than reference vessel diameter but not more than 0.5 mm smaller than the reference vessel diameter. a residual diameter stenosis prior to study device implantation by visual estimate is recommended to be \< 30%. general exclusion criteria: * acute myocardial infarction with killip class iii and iv * known history of chronic heart failure with lvef \< 30% * life expectancy \< 2 years * patients on renal dialysis or with known egfr \< 30 ml/min * planned surgery necessitating interruption of dual antiplatelet therapy within 6 months after the index procedure * known intolerance to components of the study device or control stent or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy) * patient has a current diagnosis of active covid-19 disease * patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (such as, anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint * known pregnancy or breastfeeding * patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason * subject has undergone prior pci in a target vessel during the last 12 months. (a target lesion can be randomized and treated if a vessel contains a stent older than 12 months if the stent is more than 10 mm from the intended target lesion.) angiographic exclusion criteria: * lesions in the left main artery * venous or arterial bypass grafts * in-stent restenosis * chronic total occlusion * ostial lesions (\< 3 mm of the ostium of the rca, lad or lcx) * prior stent located in a non-target vessel \< 48 hours prior to the index procedure * lesion with severe calcification and/or tortuosity requiring the planned use of a guide extension catheter, rotablation or atherectomy * bifurcation lesions requiring a planned 2 or more stent technique