- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761578
ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent
January 13, 2015 updated by: Arterial Remodeling Technologies
First in Man Safety Evaluation of the ART18Z Bioresorbable Stent for the Treatment of Single de Novo Lesion of a Native Coronary Artery.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ollioules, France
- Polyclinique les Fleurs
-
Paris, France
- Hopital Europeen Georges Pompidou
-
Pessac, France
- Hopital Haut Leveque
-
Toulouse, France
- Hopital Rangueil
-
Toulouse, France
- Clinique Pasteur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ART18Z Bioresorbable stent
|
The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE rate
Time Frame: at 6 months
|
Major Adverse Cardiac Event is defined as death, MI (Myocardial Infarction) or any TLR (Target Lesion Revascularization).
|
at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute Performances (Device/Procedure Success)
Time Frame: Procedure and post-procedure up to 24 hours
|
Procedure and post-procedure up to 24 hours
|
Stent thrombosis
Time Frame: at 1, 3, 6, 12, 18 months
|
at 1, 3, 6, 12, 18 months
|
Clinically driven TVF, TLR, TVR
Time Frame: at 1, 3, 6, 12, 18 months
|
at 1, 3, 6, 12, 18 months
|
Evolution of Angiographic binary restenosis
Time Frame: at 12 months
|
at 12 months
|
Evolution of Angiographic in-stent Late Lumen Loss
Time Frame: at 12 months
|
at 12 months
|
Percentage of stent coverage by OCT
Time Frame: at 12 months
|
at 12 months
|
Evolution of the neointima by OCT
Time Frame: at 12 months
|
at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 3, 2013
First Submitted That Met QC Criteria
January 4, 2013
First Posted (Estimate)
January 7, 2013
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARTDIVA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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