Coronary Artery Disease
Conditions
Keywords
Bioresorbable, Coronary, Stent, Vascular Remodeling, Angioplasty, Coronary Artery Disease
Brief summary
This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.
Interventions
DEVICEART18Z Bioresorbable stent
The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.
Sponsors
Arterial Remodeling Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligibility: \- Healthy voluntary and women of child-bearing potential are not accepted Inclusion Criteria: Angiographic Inclusion Criteria: Target lesion must meet all of the following criteria * Single vessel lesion * De novo lesion * Located in a native coronary artery with visually estimated nominal artery diameter of 2.8 to 3.2 mm * Length ≤ 8 mm visually estimated * Located in a major artery or branch with a visually estimated stenosis \>50% and \<100% with a TIMI flow ≥1 General Inclusion Criteria: Patient profile: * Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ART18Z Bioresorbable Stent. * Patient provides written informed consent approved by the EC prior to any clinical investigation related procedure * Patient must agree to undergo all clinical investigation plan - required clinical follow-up visits, QCA, OCT * Patient must agree not to participate in any other clinical investigation for a period of 3 years following the procedure * a social security number is required, otherwise patients cannot be included in the trial. Clinical profile: * Silent ischemia, stable or unstable angina with documented ischemia (stress echocardiography, 12-lead ECG, nuclear imaging, bicycle test, Treadmill stress test) * 3 months limited clopidogrel treatment must be acceptable in compliance with patient health status * Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
Exclusion criteria
Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE rate | at 6 months | Major Adverse Cardiac Event is defined as death, MI (Myocardial Infarction) or any TLR (Target Lesion Revascularization). |
Secondary
| Measure | Time frame |
|---|---|
| Stent thrombosis | at 1, 3, 6, 12, 18 months |
| Clinically driven TVF, TLR, TVR | at 1, 3, 6, 12, 18 months |
| Evolution of Angiographic binary restenosis | at 12 months |
| Acute Performances (Device/Procedure Success) | Procedure and post-procedure up to 24 hours |
| Percentage of stent coverage by OCT | at 12 months |
| Evolution of the neointima by OCT | at 12 months |
| Evolution of Angiographic in-stent Late Lumen Loss | at 12 months |
Countries
France
Outcome results
None listed