Clinical trial NCT02317081: Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
Official title: Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Native Coronary Artery Stenosis
Lead sponsor: Axetis AG
Sponsor class: INDUSTRY
First posted: 2014-12-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-stent Late Lumen Loss (LLL) assessed by off-line QCA
timeFrame: 6 months after stent implantation
Secondary outcomes:
measure: Acute Lumen gain
timeFrame: Post intervention (1 hour)
measure: Acute area gain
timeFrame: Post intervention (1 hour)
measure: Percent Acute device success
timeFrame: 1 day post intervention
measure: late lumen loss
timeFrame: 6 months after intervention
measure: maximal neointimal thickness
timeFrame: 6 months after intervention
measure: Percent procedural success
timeFrame: post intervention (1 hour)
measure: Number of adverse cardiac events
timeFrame: 12 months after intervention
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam, Netherlands
city: Enschede
country: Netherlands
facility: Thoraxcentrum Twente, Medisch Spectrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius
Study officials:
affiliation: Cardialysis BV
name: Yvonne Teunissen, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Cardiology, Vienna, Austria
name: Mariann Gyöngyösi, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: