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The PzF Shield Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01925794
Recruitment Status : Unknown
Verified January 2017 by CeloNova BioSciences, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: COBRA PzF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: COBRA PzF Stent Device: COBRA PzF

Primary Outcome Measures :
  1. PzF Shield [ Time Frame: 270 days ]
    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 :
  1. PzF Shield: Secondary Endpoint 1 [ Time Frame: 30, 180, 270, 360, 720, 1080, 1440 and 1800 days ]
    1. All Death

  2. Pzf Shield: Secondary Endpoint 2 [ Time Frame: 30,180,270.360,720,1080,1440 and 1800 days ]
    2. Cardiac Death

  3. 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.

  4. PzF Shield- Secondary Endpoint 4 [ Time Frame: 30,180,270,360,720,1080,1440, and 1800 days ]
    MI clinically driven TLR

  5. PzF Shield-Secondary Endpoint 5 [ Time Frame: 30,180,270,360 days ]
    Stroke (Ischemic and hemorrhagic)

  6. PzF Shield- Secondary Endpoint 6 [ Time Frame: 30,180,270,360 days ]
    Clinically driven TVR

  7. PzF Shield- Secondary Endpoint 7 [ Time Frame: 30,180,270,360 days ]
    Composite Endpoint of Cardiac Death and MI

  8. PzF Shield- Secondary Endpoint 8 [ Time Frame: 30,180,360 days ]
    Target Vessel Failure

  9. PzF Shield- Secondary Endpoint 9 [ Time Frame: Hospital Discharge ]
    Bleeding or Vascular Complications at hospital Discharge

  10. PzF Shield-Secondary Endpoint 10 [ Time Frame: 30 days ]
    Early Stent Thrombosis (ARC) defined

  11. PzF Shield- Secondary Endpoint 11 [ Time Frame: 180, 270 and 360 days ]
    Late Stent Thrombosis

  12. PzF Shield-Secondary Endpoint 12 [ Time Frame: 270 days ]
    Angiographic Endpoints

  13. PzF Shield- Secondary Endpoint 13 [ Time Frame: 270 days ]
    Optical Coherence Tomography Endpoints

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 </= 4.0 mm in diameter by visual estimate.
  3. Target lesion </= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
  4. Protected left main lesion with >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) </= 3 days prior to enrollment.
  17. Thrombocytopenia (platelets < 100,000/mm3) pre-procedure.
  18. Active peptic ulcer or active GI bleeding.
  19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  20. 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.
  21. Serum creatinine level > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01925794

Show Show 35 study locations
Sponsors and Collaborators
CeloNova BioSciences, Inc.
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Principal Investigator: Donald Cutlip, MD Executive Director, Clinical Investigation, Harvard Clinical Research Institute
Principal Investigator: Sigmund Sliber, MD Professor of Medicine at The University of Munich
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Responsible Party: CeloNova BioSciences, Inc. Identifier: NCT01925794    
Other Study ID Numbers: COBRA 2012-01
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by CeloNova BioSciences, Inc.:
Stent, Coronary Arteries for Early healing
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases