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

NCT ID: NCT02317081

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-07-31

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.

Conditions

Native Coronary Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Axetis Inert Coronary Stents

Axetis Inert Coronary Stents for de novo coronary lesion

Group Type: EXPERIMENTAL

Axetis Inert Coronary Stents

Intervention Type: DEVICE

de novo coronary artery stenosis in native vessels

Interventions

Axetis Inert Coronary Stents

de novo coronary artery stenosis in native vessels

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axetis AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Teunissen, PhD

Role: STUDY_DIRECTOR

Cardialysis BV

Mariann Gyöngyösi, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Cardiology, Vienna, Austria

Locations

AMC Amsterdam, Netherlands

Amsterdam, , Netherlands

Site Status: RECRUITING

Thoraxcentrum Twente, Medisch Spectrum

Enschede, , Netherlands

Site Status: RECRUITING

St. Antonius

Nieuwegein, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Silvio Schaffner

Role: CONTACT

axetis@gmx.ch

Facility Contacts

Joanna Wykrzykowska, MD PhD FESC

Role: primary

J.J.Wykrzykowska@amc.uva.nl

+31630387425

Clemens Von Birgelen, MD

Role: primary

c.vonbirgelen@mst.nl

+31053489

Benno Rensing, MD

Role: primary

b.rensing@wxs.nl

+31306092274

Other Identifiers

AXETIS FIM

Identifier Type: -

Identifier Source: org_study_id