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Coronary Artery DiseasePhase 2NCT00744107

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

A Phase 2 study testing PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System in people with Coronary Artery Disease, run by Medlogics Device Corporation at 7 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 … Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
Type of treatment
Medical device
How many people
258 participants
Where
7 sitesin 4 countries
Study dates
Aug 2008to Sep 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Germany3 sites

  • Main Taunus Kliniken, Kardiologisches

    Bad Soden, 65812

  • St. Vincenz Krankenhaus

    Essen, 45141

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

Other trials in Germany

United Kingdom2 sites

  • Royal Infirmary

    Edinburgh, EH16 4SA

  • Golden Jubilee Hospital

    Glasgow, G81 4HX

Other trials in United Kingdom

Israel1 site

  • Hadassah Hebrew University Medical Center

    Jerusalem, 91120

Other trials in Israel

Netherlands1 site

  • Catharina-Ziekenhuis

    Eindhoven, 5623 EJ

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
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
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI with the Cobra™ Cobalt Super Alloy Coronary Stent SystemDevice

    stent placement, single-arm study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 270 days

Secondary outcomes (1)

  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

    Measured: 30-, 180- and 270-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2010 (estimated)
  4. Study completionSep 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00744107
Sponsor's protocol ID
59-2004
Status last verified
Apr 2009
First submitted
27 Aug 2008
Last updated
6 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System in people with Coronary Artery Disease, run by Medlogics Device Corporation at 7 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, United Kingdom, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00744107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.

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