An Exploratory Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of JFK-01 (Coronary Artery Absorbable Magnesium Alloy Scaffold) in Patients with Ischemic Heart Disease
Exploratory Trial of JFK-01 (Coronary Artery Absorbable Magnesium Alloy Scaffold)
Nakazawa Gaku
Kindai University Hospital
377-2, Ohnohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
General Inclusion Criteria
1. Age greater than or equal to 20 years old
2. patients who have been fully informed about the study device and the purpose and content of the study, and who have voluntarily agreed in writing to participate in the study.
3. patients with evidence of ischaemic heart disease (stable angina pectoris, unstable angina pectoris, asymptomatic ischaemia) and who are indicated for standby PCI
4. patients for whom coronary artery bypass grafting (CABG) can be performed in an emergency
5. patients who can continue on dual antiplatelet therapy throughout the study period
6. patients who can be anticoagulated for PCI procedures
7. for women, patients who are not pregnant or lactating at the time of screening and have no plans to do either within 13 months
8. patients with a negative pregnancy test within 7 days prior to the procedure (except for patients who are clearly not pregnant)
9. patients who can agree not to participate in other interventional clinical trials until the 13-month follow-up is completed.
Imaging Inclusion Criteria
1. De Novo Coronary Lesions
2. One lesion or two lesions in one or two branches that are eligible for PCI
3. Lesions with visual diameter stenosis (AHA stenosis classification) greater than 75% and less than 100%.
4. Lesions with TIMI classification grade 1 or higher blood flow
5. Lesions with a visual control vessel diameter of 3 mm and lesion length of 18 mm or less
General Exclusion Criteria
1. patients who need to discontinue aspirin or thienopyridine antiplatelet medication or who are scheduled to undergo surgery requiring general anaesthesia
2. known hypersensitivity to raw materials of the test device (e.g. magnesium, magnesium fluoride, zinc, zirconium, manganese, tantalum and parylene,PLCL, PDLLAand sirolimus), contrast media and antiplatelet agents, which is not controlled by premedication with drugs 3. patients with known hypersensitivity to contrast media and antiplatelet agents
3. Patients who have had an acute myocardial infarction within 72 hours prior to the investigational procedure, including any of the following
(1)Patients with clinical findings specific to the development of acute myocardial infarction (e.g. persistent chest pain not responding to nitrates and ischaemic ECG changes)
(2) pre-procedure CK-MB values above the upper reference limit
4. patients with unstable arrhythmias with potentially unstable haemodynamic status
5. patients with a left ventricular ejection fraction of less than 30%.
6. patients who have undergone PCI within the last 90 days
7. patients scheduled to undergo PCI for non-target vessels within 6 months
8. patients with malignancies not in remission
9. patients on immunosuppressive drugs or with life-threatening immunosuppressive or life-threatening autoimmune diseases (e.g. systemic lupus erythematosus, etc.)
10. patients who have undergone or are awaiting organ transplantation.
11. patients who have undergone or will undergo radiation therapy to the chest or mediastinum
12. patients with a platelet count below 100 000 cells/mm3 or above 700 000 cells/mm3
13. patients with or suspected of having severe liver cirrhosis.
14. Patients with renal insufficiency corresponding to any of the following
(1)On dialysis
(2) eGFR less than 30 ml/min/1 .73mm2
15. Patients at high risk of bleeding or difficult to be treated appropriately and who fall into one of the following categories
(1)Bleeding constitution, coagulopathy
(2)Serious gastrointestinal bleeding or serious urinary tract bleeding within the last 6 months
16. history of intracranial bleeding
17. patients with known intracranial pathology (e.g. untreated intracranial aneurysm > 5 mm, cerebral arteriovenous malformation) that the physician considers to be at high risk of intracranial bleeding
18. patients who are taking antiplatelet agents other than aspirin and thienopyridine antiplatelet agents and who are unable to discontinue these agents
19. patients who have had a cerebrovascular attack (including transient ischaemic attack) within the last 6 months
20. patients with peripheral vascular disorders that make insertion of a 7Fr guiding catheter difficult through any vascular access
21. patients who are judged by the physician in charge to be unable to fulfil the 5-year observation period of this trial
22. patients who have difficulty in complying with the study protocol or who, for any reason, are deemed by the physician to be unfit to participate in the study.
23. patients who are participating in a clinical trial with an intervention and for whom the evaluation of the primary endpoint has not been completed
Imaging Exclusion Criteria
1. highly calcified lesions for which angioplasty by balloon dilation (POBA, cutting balloon, or scoring balloon) appears to be infeasible
2. any of the following lesions or lesions for which adequate delivery of the device under study is not feasible
(1)Severe bending of the target lesion or near site of the target lesion
(2)severe tortuosity of the target lesion or near site of the target lesion (more than 2 bends of 45 degrees or more exist)
3. left main stem artery lesion
4. Bifurcation lesion in which the side branch is jailed by struts due to the implantation of the device in one of the following cases
(1)lesions containing a side branch with a vessel diameter of 2 mm or greater
(2)lesions requiring pre-dilation of the side branch (including kissing balloon)
(3)lesions requiring a protective guidewire
5. lesion within 3 mm from the entrance of the right coronary artery
6. lesion within 3 mm of the origin of the left anterior descending branch of the coronary artery or the left circumflex branch of the coronary artery
7. bypass graft lesions or lesions distal to the bypass graft anastomosis
8. lesions with thrombus in the target vessel on pre-procedure angiography, IVUS, or OCT
20age old over
No limit
Both
ischemic heart disease
Main clinical endpoints
Procedural success
Clinical success
Major cardiac events (MACE)
Target vessel failure (TVF)
Haemorrhagic events
Thrombosis (ARC definition)
Main angiographic endpoints
Late loss 13 months,2 years
Target lesion revascularisation(TLR)
Main OCT IVUS endpoints
Mean lumen area
Minimal lumen cross sectional area
Malapposition
Japan Medical Device Technology Co.,Ltd.
Clinical Trial Review Board of Kindai University Hospital
377-2, Ohnohigashi, Osaka-Sayama City, Osaka Prefecture, Japan, Osaka
