Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Medlogics Device Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Harvard Clinical Research Institute
Stanford University
Information provided by:
Medlogics Device Corporation
ClinicalTrials.gov Identifier:
NCT00744107
First received: August 27, 2008
Last updated: August 4, 2009
Last verified: April 2009
  Purpose

To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.


Condition Intervention Phase
Coronary Artery Disease
Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Further study details as provided by Medlogics Device Corporation:

Primary Outcome Measures:
  • Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods. [ Time Frame: 270 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACE defined as all-cause death, MI, emergent CABG, or clinically driven TLR; TVF; 6 month In-segment %DS, late lumen loss, binary restenosis and In-stent %DS,late lumen loss, binary restenosis, MLD [ Time Frame: 30-, 180- and 270-days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 258
Study Start Date: August 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
    stent placement, single-arm study
Detailed Description:

Safety and Efficacy will be demonstrated by the rate of Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) [Q wave or non-Q wave], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days of the post-stent placement procedure.

Additionally, Major Adverse Cardiac Events (MACE)at 30, 180 and 270 days defined as a composite of all-cause death, myocardial infarction (MI) (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)]will be documented.

  Eligibility

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

Inclusion Criteria:

  • The subject is ≥ 18 years old;
  • Subject is eligible for percutaneous coronary intervention (PCI), stent placement, and emergent coronary artery bypass graft (CABG) surgery;
  • Subject has clinical evidence of ischemic heart disease, stable or unstable angina or silent ischemia;
  • The subject has a documented left ventricular ejection fraction (LVEF) ≥ 30%;
  • The subject or legal representative has been informed of the clinical study and the required follow-up procedures and must provide written informed consent using a form that is reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) for the clinical site;
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days before treatment;
  • Subject must agree to comply with the required follow-up procedures (including antiplatelet regimen) to the best of their ability, be geographically available for all study follow-up procedures and visits and not have a known medical condition that precludes completion of the required follow-up visits;
  • The lesion is either de novo or restenotic (previously unstented) in nature, located in a native coronary artery AND is ≥ 50% and < 100% stenosed by visual estimate or on-line QCA;
  • The target vessel reference diameter ≥ 2.5mm and ≤ 4mm by visual estimate and is appropriate for treatment with available stent diameters of 2.5 mm, to 4.0 mm;
  • The lesion length is ≤ 26 mm and able to accommodate placement of a single stent;
  • The target lesion is a minimum of 15 mm from any previously placed stent; AND
  • The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2

Exclusion Criteria:

  • The subject has a known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, ticlopidine and clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated;
  • A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a WBC < 3,000 cells/mm³;
  • A creatinine level > 2.5 mg/dL within 7 days prior to the index procedure;
  • Evidence of an acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q wave (QWMI) or any elevation of creatine kinase myocardial-band (CK-MB) isoenzyme elevated above the Institution's upper limit of normal;
  • Any previous PCI (with or without stent) of the target vessel within 30 days prior to the index procedure;
  • Previous stent placement anywhere in the target lesion;
  • Previous drug eluting stent (DES) deployment anywhere in the target vessel;
  • The subject requires staged procedure of any non-target vessel within 30 days post-procedure;
  • The subject requires staged procedure of the target vessel within 9 months post-procedure;
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.;
  • History of a stroke or transient ischemic attack (TIA) within the previous 6 months;
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the previous 6 months;
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions;
  • A known concurrent medical condition resulting in a life expectancy of less than 12 months;
  • Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy;
  • The subject is currently participating in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial; or interferes with the current trial endpoints; or the subject has previously been enrolled in the study;
  • The subject has a known medical condition that will cause them to be non-compliant with the study protocol or confound the data interpretation;
  • The target vessel has evidence of thrombus or other lesions having a > 60% stenosis by visual estimate or on-line QCA;
  • Target vessel exhibiting multiple 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;
  • The target vessel has evidence (visual or QCA) of excessive tortuosity (two or more 90° bends prior to the target lesion) or is severely calcified; OR
  • The target lesion is in an unprotected left main, involves a side branch vessel having a diameter of > 2.0 mm or is at the aorto-ostial location
  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: NCT00744107

Locations
Germany
Main Taunus Kliniken, Kardiologisches
Bad Soden, Germany, 65812
St. Vincenz Krankenhaus
Essen, Germany, 45141
Krankenhaus der Barmherzigen Brüder
Trier, Germany, 54292
Israel
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120
Netherlands
Catharina-Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
United Kingdom
Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Golden Jubilee Hospital
Glasgow, United Kingdom, G81 4HX
Sponsors and Collaborators
Medlogics Device Corporation
Harvard Clinical Research Institute
Stanford University
Investigators
Principal Investigator: Prof. Nicolaus J Reifart, PhD, MD Main Taunus Kliniken, Kardiologisches
  More Information

No publications provided

Responsible Party: Medlogics Device Corporation
ClinicalTrials.gov Identifier: NCT00744107     History of Changes
Other Study ID Numbers: 59-2004
Study First Received: August 27, 2008
Last Updated: August 4, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Medlogics Device Corporation:
Ischemic coronary artery disease in native coronary arteries
Single stent
RVD 2.5- 4.0mm
Lesion length up to 26mm
de novo or previously unstented lesions

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Cobalt
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 30, 2014