ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

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 Exclusion Criteria:

• Target lesion meets any of the following criteria:
• Aorto-ostial location (within 3 mm)
• Left main location
• located within 3 mm of the origin of the LAD or LCX
• Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and >20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
• Lesion involving a bifurcation ≥ 1.5 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
• Excessive tortuosity proximal to or within the lesion (Extreme angulation (≥ 90%) proximal)
• Calcification lesion
• Restenotic from previous intervention
• The target vessel contains visible thrombus
• Chronic total occlusion (CTO)
• Another clinically significant lesion is located in the same major epicardial vessel as the target lesion (including side branches)
• Patient has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)
• Non clinical investigation percutaneous intervention in the target vessel < 6 months prior to or if planned to be done within 6 months after the investigational procedure.
• Non clinical investigation percutaneous intervention in a non-target vessel < 1 months prior to the investigational procedure with TIMI flow = 3 and no evidence of dissection at the time of the clinical investigation procedure, or if planned to be done within 6 months after the investigational procedure.

General Exclusion Criteria

• Evidence of an acute MI within 3 weeks of the intended investigational procedure
• Patient has current unstable arrhythmias
• Patient has a known left ventricular ejection fraction (LVEF) < 30%
• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, or contrast sensitivity that cannot be adequately pre-medicated
• Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
• Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Patient has known renal insufficiency with creatine clearance < 40 ml/min or patient on dialysis
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has had a cerebro vascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
• Patient has had a significant GI or urinary bleed within the past six months
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
• Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a < 24 months limited life expectancy
• Vulnerable population (refer to §6.4)
• Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
• Pregnant or nursing patients and those who plan pregnancy during the clinical investigation.