COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding… (NCT01925794) | Clinical Trial Compass
CompletedNot Applicable
COBRA PZFâ„¢ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
United States296 participantsStarted 2013-08-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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).
✓. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.
. 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.