Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Infinity-Swedeheart Study: Registry Based Randomized Clinical Trial (R-RCT) Comparing Long Term Outcomes of the DynamX Bioadaptor to the Resolute Onyx Stent in a More-comer PCI Patient Population

Conditions
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Coronary Artery Disease, Ischemic Heart Disease

Intervention / Treatment
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* Device: DynamX Bioadaptor
* Device: Resolute Onyx


Participation Criteria
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Eligibility Criteria
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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). 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). 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. If a planned Non-Target Lesion is present it must have been treated without complication* prior to randomization. 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 requiring rotablation or atherectomy Bifurcation lesions requiring a planned 2 or more stent technique

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DynamX Bioadaptor<br>Elixir Medical DynamX™ Sirolimus Eluting Coronary Bioadaptor | Device: DynamX Bioadaptor<br>* DynamX Bioadaptor Treatment<br>|
| Active Comparator: Medtronic Resolute Onyx Stent<br>Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device: Resolute Onyx<br>* Resolute Onyx Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Lesion-Level Analysis | During Study Procedure | 
| Procedural Success | Patient-Level Analysis | In-Hospital, assessed up to 7 days | 
| Composite Rate of Device Oriented Clinical Endpoint (DOCE) | Composite Device Oriented Clinical Endpoint (DOCE) (TLF; cardiovascular death, TV-MI, ischemia-driven TLR) | 30 days, 6 months, 1-5 years | 
| Composite Rate of Patient Oriented Clinical Endpoint (POCE) | Composite Patient Oriented Clinical Endpoint (POCE) (all-cause mortality, any stroke, any myocardial infarction (includes non-target vessel territory) and any revascularization). Note: Stroke to be collected and included in the POCE at 1 year and 5 years only. | 30 days, 6 months, 1-5 years | 
| Rate of Target Vessel Failure (TVF) | Target vessel failure (TVF; cardiovascular death, target vessel myocardial infarction (TV-MI), or target vessel revascularization (TVR)) | 30 days, 6 months, 1-5 years | 
| Composite Rate of cardiovascular death, any myocardial infarction and any revascularization | Composite of cardiovascular death, any myocardial infarction and any revascularization | 30 days, 6 months, 1-5 years | 
| Rate of Ischemia driven target lesion revascularization (ID-TLR) | Ischemia driven target lesion revascularization (ID-TLR) | 30 days, 6 months, 1-5 years | 
| Rate of Target Lesion Revascularization (TLR) | All Target Lesion Revascularization | 30 days, 6 months, 1-5 years | 
| Rate of Target Vessel Revascularization (TVR) | All Target Vessel Revascularization | 30 days, 6 months, 1-5 years | 
| Rate of Ischemia driven target vessel revascularization (ID-TVR) | Ischemia driven target vessel revascularization (ID-TVR) | 30 days, 6 months, 1-5 years | 
| Rate of Ischemia driven non target vessel revascularization (ID-NTVR) | Ischemia driven non target vessel revascularization (ID-NTVR) | 30 days, 6 months, 1-5 years | 
| Rate of Non target vessel revascularization (NTVR) | Non target vessel revascularization (NTVR) | 30 days, 6 months, 1-5 years | 
| Rate of All revascularization | All revascularization | 30 days, 6 months, 1-5 years | 
| Rate of Myocardial Infarction | All MI, Q-Wave and Non Q-Wave MI, TV-MI, NTV-MI | 30 days, 6 months, 1-5 years | 
| Rate of Death | Cardiovascular Death, All-Cause Death | 30 days, 6 months, 1-5 years | 
| Composite: Cardiovascular death or myocardial infarction | Composite: Cardiovascular death or myocardial infarction | 30 days, 6 months, 1-5 years | 
| Composite: All-cause death or myocardial infarction | Composite: All-cause death or myocardial infarction | 30 days, 6 months, 1-5 years | 
| Composite: All-cause death, myocardial infarction or target vessel revascularization | Composite: All-cause death, myocardial infarction or target vessel revascularization | 30 days, 6 months, 1-5 years | 
| Rate of any stroke | Any stroke (collected at 1 year and 5 years only) | 1 year and 5 years | 
| Anginal Status | Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7) | 30 days and 1 year | 
| Rate of Stent Thrombosis | Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis | 30 days, 6 months, 1-5 years |