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

Arterial Remodeling Technologies

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: ART18Z Bioresorbable stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01761578

ARTDIVA

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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.