The PzF Shield Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by CeloNova BioSciences, Inc.
Sponsor:
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT01925794
First received: August 9, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Coronary Artery Disease
Device: COBRA PzF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by CeloNova BioSciences, Inc.:

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

  • Pzf Shield: Secondary Endpoint 2 [ Time Frame: 30,180,270.360,720,1080,1440 and 1800 days ] [ Designated as safety issue: Yes ]
    2. Cardiac Death

  • PzF Shield-Secondary Endpoint 3 [ Time Frame: 30,180,270,360,720,1080,1440, and 1800 days ] [ Designated as safety issue: Yes ]
    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.

  • PzF Shield- Secondary Endpoint 4 [ Time Frame: 30,180,270,360,720,1080,1440, and 1800 days ] [ Designated as safety issue: Yes ]
    MI clinically driven TLR

  • PzF Shield-Secondary Endpoint 5 [ Time Frame: 30,180,270,360 days ] [ Designated as safety issue: Yes ]
    Stroke (Ischemic and hemorrhagic)

  • PzF Shield- Secondary Endpoint 6 [ Time Frame: 30,180,270,360 days ] [ Designated as safety issue: Yes ]
    Clinically driven TVR

  • PzF Shield- Secondary Endpoint 7 [ Time Frame: 30,180,270,360 days ] [ Designated as safety issue: Yes ]
    Composite Endpoint of Cardiac Death and MI

  • PzF Shield- Secondary Endpoint 8 [ Time Frame: 30,180,360 days ] [ Designated as safety issue: Yes ]
    Target Vessel Failure

  • PzF Shield- Secondary Endpoint 9 [ Time Frame: Hospital Discharge ] [ Designated as safety issue: Yes ]
    Bleeding or Vascular Complications at hospital Discharge

  • PzF Shield-Secondary Endpoint 10 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Early Stent Thrombosis (ARC) defined

  • PzF Shield- Secondary Endpoint 11 [ Time Frame: 180, 270 and 360 days ] [ Designated as safety issue: Yes ]
    Late Stent Thrombosis

  • PzF Shield-Secondary Endpoint 12 [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    Angiographic Endpoints

  • PzF Shield- Secondary Endpoint 13 [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]
    Optical Coherence Tomography Endpoints


Estimated Enrollment: 296
Study Start Date: August 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COBRA PzF Stent Device: COBRA PzF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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% at the most recent evaluation.
  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 60% 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925794

Contacts
Contact: Jane Hart 210 489 4025 jhart@celonova.com
Contact: Mark Barakat mbarakat@celonova.com

  Show 36 Study Locations
Sponsors and Collaborators
CeloNova BioSciences, Inc.
Investigators
Principal Investigator: Donald Cutlip, MD Executive Director, Clinical Investigation, Harvard Clinical Research Institute
  More Information

No publications provided

Responsible Party: CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01925794     History of Changes
Other Study ID Numbers: COBRA 2012-01
Study First Received: August 9, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Ethics Commission
Latvia: Institutional Review Board
Serbia: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Switzerland: Ethikkommission

Keywords provided by CeloNova BioSciences, Inc.:
Stent, Coronary Arteries for Early healing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014