Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment cobra pzf
Sponsor CeloNova BioSciences, Inc.
Start date August 2013
End date November 2015
Trial size 296 participants
Trial identifier NCT01925794, COBRA 2012-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cobra pzf

Primary Outcomes

Measure
PzF Shield
time frame: 270 days

Secondary Outcomes

Measure
PzF Shield: Secondary Endpoint 1
time frame: 30, 180, 270, 360, 720, 1080, 1440 and 1800 days
Pzf Shield: Secondary Endpoint 2
time frame: 30,180,270.360,720,1080,1440 and 1800 days
PzF Shield-Secondary Endpoint 3
time frame: 30,180,270,360,720,1080,1440, and 1800 days
PzF Shield- Secondary Endpoint 4
time frame: 30,180,270,360,720,1080,1440, and 1800 days
PzF Shield-Secondary Endpoint 5
time frame: 30,180,270,360 days
PzF Shield- Secondary Endpoint 6
time frame: 30,180,270,360 days
PzF Shield- Secondary Endpoint 7
time frame: 30,180,270,360 days
PzF Shield- Secondary Endpoint 8
time frame: 30,180,360 days
PzF Shield- Secondary Endpoint 9
time frame: Hospital Discharge
PzF Shield-Secondary Endpoint 10
time frame: 30 days
PzF Shield- Secondary Endpoint 11
time frame: 180, 270 and 360 days
PzF Shield-Secondary Endpoint 12
time frame: 270 days
PzF Shield- Secondary Endpoint 13
time frame: 270 days

Eligibility Criteria

Male or female participants at least 18 years old.

General Inclusion Criteria: 1. Patient >/= to 18 years old. 2. Eligible for percutaneous coronary intervention (PCI). 3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure. 4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone. 5. Acceptable candidate for coronary artery bypass graft (CABG) surgery. 6. 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). 7. 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 1. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery. 2. Reference vessel >/= 2.5 mm and 50% stenosis. 5. Target lesion stenosis >/= 70% and < 100% by visual estimate. 6. Target lesion stenosis <70% who meet physiological criteria for revascularization (i.e. positive FFR). General Exclusion Criteria: 1. 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. 2. Previously enrolled in another stent trial within the prior 2 years. 3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months. 4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure. 5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure. 6. 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.). 7. Previous drug eluting stent (DES) deployment anywhere in the target vessel. 8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion. 9. 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. 10. Concurrent medical condition with a life expectancy of less than 12 months. 11. Documented left ventricular ejection fraction (LVEF) < 30% within 12 months prior to enrollment. 12. 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 13. Previous brachytherapy in the target vessel. 14. History of cerebrovascular accident or transient ischemic attack in the last 6 months. 15. Leukopenia (leukocytes < 3.5 x 10(9) / liter). 16. Neutropenia (Absolute Neutrophil Count < 1000/mm3) 2.0 mg/dl within 7 days prior to index procedure. 22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure. Angiographic Exclusion Criteria 1. 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). 2. 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. 3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time. 4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX). 5. Target lesion with side branches > 2.0mm in diameter. 6. Target vessel is excessively tortuous (two bends > 90˚ to reach the target lesion). 7. Target lesion is severely calcified. 8. TIMI flow 0 or 1 9. Target lesion is in a bypass graft

Additional Information

Official title COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy
Principal investigator Donald Cutlip, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by CeloNova BioSciences, Inc..