Native Coronary Artery Stenosis
Conditions
Brief summary
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
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.
Interventions
DEVICEAxetis Inert Coronary Stents
de novo coronary artery stenosis in native vessels
Sponsors
Axetis AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent Late Lumen Loss (LLL) assessed by off-line QCA | 6 months after stent implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute area gain | Post intervention (1 hour) | Optical coherence tomography end point |
| Percent Acute device success | 1 day post intervention | 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 |
| late lumen loss | 6 months after intervention | Angiographic endpoint |
| Acute Lumen gain | Post intervention (1 hour) | Angiographic endpoint MLD (mm); Diameter Stenosis (%); Binary Restenosis (DS ≥50%) |
| Percent procedural success | post intervention (1 hour) | — |
| Number of adverse cardiac events | 12 months after intervention | clinical endpoint |
| maximal neointimal thickness | 6 months after intervention | OCT |
Countries
Netherlands
Contacts
Primary ContactSilvio Schaffner
Outcome results
None listed