COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT

NCT01925794 | Completed Results DMC

• 1 other identifier: COBRA 2012-01
• Study Type: interventional
• Target: 296
• Locations: 7 countries
• Sites: 35

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.

Conditions

Coronary Artery Disease

Keywords

Stent, Coronary Arteries for Early healing

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  TVF defined as cardiac death, target vessel myocardial infarction (MI \[Q wave or non-Q wave, ARC definition\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.

  270 days

Secondary Outcomes (58)

• All Cause Mortality

  30 days

• All Cause Mortality

  180 days

• All Cause Mortality

  270 days

• All Cause Mortality

  360 days

• All Cause Mortality

  1800 days

Study Arms (1)

COBRA PzF Stent

EXPERIMENTAL

Single Arm study

Device: COBRA PzF

Interventions

COBRA PzF DEVICE

COBRA PzF Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Reference vessel \>/= 2.5 mm and \</= 4.0 mm in diameter by visual estimate.
• Target lesion \</= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).
• Protected left main lesion with \>50% stenosis.
• Target lesion stenosis \>/= 70% and \< 100% by visual estimate.
• Target lesion stenosis \<70% who meet physiological criteria for revascularization (i.e. positive FFR).

You may not qualify if:

• 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% within 12 months prior to enrollment.
• 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 x 10(9) / liter).

Sponsors & Collaborators

• CeloNova BioSciences, Inc.: lead

Study Sites (35)

Bakersfield Memorial Hospital

Bakersfield, California, 93303, United States

Location

Mt Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Louisiana Heart Hospital

Lacombe, Louisiana, 70445, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

St Joseph's Hospital

Liverpool, New York, 13088, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Mount Sinai Hospital

New York, New York, 11029, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Southern Oregon Cardiology

Medford, Oregon, 97504, United States

Location

York General Hospital

York, Pennsylvania, 17403, United States

Location

Cardiology Consultants of Texas

Dallas, Texas, 75226, United States

Location

Plaza Medical Center

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Cardiac Center

Lubbock, Texas, 79410, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

San Antonio Endovascular & Heart Institute

San Antonio, Texas, 78258, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, 54401, United States

Location

Clinique Axium

Aix-en-Provence, 13097, France

Location

Hopital Henri Duffaut

Avignon, 84902, France

Location

Albert Schweitzer Hospital

Colmar, 68000, France

Location

Clinique du Diaconat

Mulhouse, 68100, France

Location

Centre Hospitalier de Pau

Pau, 64046, France

Location

Clinique St. Hilaire

Rouen, 76600, France

Location

Sankt Kathatinen Hospital

Frankfurt, 60389, Germany

Location

Kardiologische Praxis und Praxisklinik

München, 81379, Germany

Location

Paul Stradins Clinical University Hospital

Riga, 2166, Latvia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Hospital de la Santa Creu

Barcelona, 08025, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Mark Barakat, MD
• Organization: CeloNova BioSciences Inc.

mbarakat@celonova.com

(210) 489-4004

Study Officials

• Donald Cutlip, MD

  Executive Director, Clinical Investigation, Harvard Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Sigmund Sliber, MD

  Professor of Medicine at The University of Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 20, 2013
• Study Start: August 21, 2013
• Primary Completion: November 1, 2015
• Study Completion: March 2, 2020
• Last Updated: December 22, 2021
• Results First Posted: December 22, 2021

Record last verified: 2021-03

Locations

ES (2); CH (1); LA (1); DE (2); SE (1); US (22); FR (6)