COBRA PzF

  • STATUS
    Recruiting
Send
Updated on 8 November 2020
See if I qualify

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.

Details
Clinical Study IdentifierTX138734
Last Modified on8 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Patient 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note