COBRA PzF

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

COBRA PzF

Description

This is a non-randomized, multi-center, prospective, single arm, controlled clinical study to collect information about the safety and effectiveness of the COBRA PzFTM Coronary Stent System in the treatment of de novo stenotic lesions in native coronary arteries.

IRB Number: 014-069

Details
Clinical Study IdentifierTX138923
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Patient is at least 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)

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% at the most recent evaluation
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 × 109 / liter)
Neutropenia (Absolute Neutrophil Count < 1000/mm3) £ 3 days prior to enrollment
Thrombocytopenia (platelets < 100,000/mm3) pre-procedure
Active peptic ulcer or active GI bleeding
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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