Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)

Study Overview
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Brief Summary
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Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.

Detailed Description
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Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at 6 months follow-up. All patients will undergo Optical coherence Tomography (OCT) investigation at baseline (post procedure) and at 6 months follow-up. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation.

Official Title
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Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)

Conditions
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Native Coronary Artery Stenosis

Intervention / Treatment
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* Device: Axetis Inert Coronary Stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years Evidence of myocardial ischemia without elevatedTroponin / cardiac biomarkers (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). NSTEMI patients are allowed, as long as Troponin is within the normal limits before the start of the procedure. The patient has a planned intervention of up to two de-novo lesions in two different vessels (previously untreated vessels) Lesion must have a visually estimated diameter stenosis of ≥50% and <100%. Lesion length must be ≤ 28 mm RVD must be between 2.4 and 3.8 mm Written informed consent The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT control at 6 months Exclusion Criteria: Evidence of ongoing acute myocardial infarction in ECG and or elevated cardiac biomarkers prior to procedure. LVEF <30% Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) Known renal insufficiency (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis) History of bleeding diathesis or coagulopathy The patient is a recipient of a heart transplant Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticagrelor and ticlopidine) or stainless steel Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter Target lesion in left main stem. Target lesion involves a side branch > 2.0mm in diameter Aorto-ostial target lesion (within 3 mm of the aorta junction). Total occlusion or TIMI flow 1, prior to wire crossing The target vessel contains visible thrombus Restenotic lesion Target vessel with previously placed stent or with graft Located within an arterial or saphenous vein graft Treatment of more than 1 lesion in one vessel, or treatment of more than two lesions

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axetis Inert Coronary Stents<br>Axetis Inert Coronary Stents for de novo coronary lesion | Device: Axetis Inert Coronary Stents<br>* de novo coronary artery stenosis in native vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss (LLL) assessed by off-line QCA |  | 6 months after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Lumen gain | Angiographic endpoint MLD (mm); Diameter Stenosis (%); Binary Restenosis (DS ≥50%) | Post intervention (1 hour) | 
| Acute area gain | Optical coherence tomography end point | Post intervention (1 hour) | 
| Percent Acute device success | Device-oriented Composite Endpoints (DoCE) at 6 months and 12 months (DoCE is defined as Cardiac Death, MI not clearly attributable to a nonintervention vessel, and clinically-indicated Target Lesion Revascularization and its individual components) Stent thrombosis according to the ARC definitions up to 12 months follow-up | 1 day post intervention | 
| late lumen loss | Angiographic endpoint | 6 months after intervention | 
| maximal neointimal thickness | OCT | 6 months after intervention | 
| Percent procedural success |  | post intervention (1 hour) | 
| Number of adverse cardiac events | clinical endpoint | 12 months after intervention |