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

NCT00744107 | Unknown Phase 2 DMC

• 1 other identifier: 59-2004
• Study Type: interventional
• Target: 258
• Locations: 4 countries
• Sites: 7

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  270 days

Secondary Outcomes (1)

• 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

  30-, 180- and 270-days

Interventions

PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System DEVICE

stent placement, single-arm study

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medlogics Device Corporation: lead
• Baim Institute for Clinical Research: collaborator
• Stanford University: collaborator

Study Sites (7)

Main Taunus Kliniken, Kardiologisches

Bad Soden, 65812, Germany

Location

St. Vincenz Krankenhaus

Essen, 45141, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Catharina-Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Golden Jubilee Hospital

Glasgow, G81 4HX, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Prof. Nicolaus J Reifart, PhD, MD

  Main Taunus Kliniken, Kardiologisches

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 6, 2009

Record last verified: 2009-04

Locations

DE (3); NL (1); GB (2); IL (1)