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ClinicalTrials.gov Identifier: NCT01925794
Recruitment Status : Unknown
Verified January 2017 by CeloNova BioSciences, Inc.. Recruitment status was: Active, not recruiting
This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.
The primary endpoint will be the incidence of Target Vessel Failure (TVF) within 270 days of treatment with the COBRA PzFTM Coronary Stent System.
Secondary Outcome Measures :
PzF Shield: Secondary Endpoint 1 [ Time Frame: 30, 180, 270, 360, 720, 1080, 1440 and 1800 days ]
1. All Death
Pzf Shield: Secondary Endpoint 2 [ Time Frame: 30,180,270.360,720,1080,1440 and 1800 days ]
2. Cardiac Death
PzF Shield-Secondary Endpoint 3 [ Time Frame: 30,180,270,360,720,1080,1440, and 1800 days ]
3. Major Adverse Events (MACE), defined as cardiac death, Myocardial Infarction (MI), emergent bypass surgery, or clinically driven Target Lesion REvascularization (TLR) by percutaneous or surgical methods.
PzF Shield- Secondary Endpoint 4 [ Time Frame: 30,180,270,360,720,1080,1440, and 1800 days ]
MI clinically driven TLR
PzF Shield-Secondary Endpoint 5 [ Time Frame: 30,180,270,360 days ]
Stroke (Ischemic and hemorrhagic)
PzF Shield- Secondary Endpoint 6 [ Time Frame: 30,180,270,360 days ]
Clinically driven TVR
PzF Shield- Secondary Endpoint 7 [ Time Frame: 30,180,270,360 days ]
Composite Endpoint of Cardiac Death and MI
PzF Shield- Secondary Endpoint 8 [ Time Frame: 30,180,360 days ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
General Inclusion Criteria:
Patient >/= to 18 years old.
Eligible for percutaneous coronary intervention (PCI).
Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Acceptable candidate for coronary artery bypass graft (CABG) surgery.
Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
Angiographic Inclusion Criteria
Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
Reference vessel >/= 2.5 mm and </= 4.0 mm in diameter by visual estimate.
Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
Protected left main lesion with >50% stenosis.
Target lesion stenosis >/= 70% and < 100% by visual estimate.
Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR).
General Exclusion Criteria:
Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Previously enrolled in another stent trial within the prior 2 years.
ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
Previous drug eluting stent (DES) deployment anywhere in the target vessel.
Any previous stent placement within 15 mm (proximal or distal) of the target lesion.
Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
Concurrent medical condition with a life expectancy of less than 12 months.
Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment.
Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment
Previous brachytherapy in the target vessel.
History of cerebrovascular accident or transient ischemic attack in the last 6 months.
Leukopenia (leukocytes < 3.5 x 10(9) / liter).
Neutropenia (Absolute Neutrophil Count < 1000/mm3) </= 3 days prior to enrollment.
History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.
Angiographic Exclusion Criteria
Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).
Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.
Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time.
Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
Target lesion with side branches > 2.0mm in diameter.
Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion).