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Coronary Artery DiseaseVANTAGE-1NCT01025869

The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

A study testing Cinatra™ Corolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Atrium Medical Corporation at 4 sites in New Zealand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries. 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?
Cinatra™ Corolimus Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
4 sitesNew Zealand
Study dates
Dec 2009to Mar 2012
Phase
Interventional
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

  • Patient is ≥ 18 years old
  • Patient is an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
  • Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
  • Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
  • Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site
  • Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed
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  • Angiographic:
  • Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
  • If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
  • Residual diameter stenosis <10%
  • Absence of any angiographic complications
  • Absence of ischaemic symptoms
  • Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischaemia
  • Target lesion must be a de novo lesion in native coronary artery
  • Target lesion must be ≤ 22 mm in length
  • Target lesion must have a stenosis of ≥ 50% and < 100%
  • Target vessel must have a reference vessel diameter (RVD) appropriate for treatment with a of 3.0mm or3.5 mm stent
  • Target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2

Who cannot join

  • Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to index procedure
  • Serum creatinine level 170 micromol/L within 7 days prior to index procedure
  • Evidence of an acute myocardial infarction (MI) within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal)
  • Previous PCI of the target vessel within 9 months prior to the procedure
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  • Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
  • During the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
  • Left ventricular ejection fraction (LVEF) < 30% if evaluated, or clinical evidence of significant congestive heart failure (NYHA Class III or IV) within the prior 30 days
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Any previous treatment of the target vessel(s) for restenosis, including brachytherapy
  • 16. Any condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study 17. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
  • Angiographic:
  • Target lesion is located in native vessel distal to anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass with more than 40% diameter stenosis anywhere within the graft
  • Previous stenting in the target vessel.
  • The target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA
  • The target vessel has evidence of thrombus
  • The target vessel is excessively tortuous (two bends > 90º to reach the target lesion)
  • The target lesion has any of the following characteristics:
  • Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX)
  • Involves a side branch > 2.0 mm in diameter
  • Is at or distal to a > 45º bend in the vessel
  • Is severely calcified
  • Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)

Trial locations and contacts

4 sites in 1 country.

New Zealand4 sites

  • Auckland City Hospital

    Auckland

  • Mercy Angiography

    Auckland

  • North Shore Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

Other trials in New Zealand

About this study

To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.

Read the detailed description

This is a single-arm, multicentre pilot study designed to provide an indication of the effectiveness and safety of the Cinatra™ Corolimus Eluting Coronary Stent System. The primary endpoint to be evaluated in this study is late lumen loss (in-stent) at 6 months post-procedure as measured by QCA in the 30 participants undergoing angiography at this timepoint. Late lumen loss is defined as the difference between the post-index procedure minimal lumen diameter (MLD) and the follow-up MLD.

Being tested
Cinatra™ Corolimus Eluting Coronary Stent System
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.

  • Cinatra™ Corolimus Eluting Coronary Stent SystemDevice

    Stent implantation

Study groups in NCT01025869
Study groupRoleWhat they receive
Stent SystemOtherCinatra™ Corolimus Eluting Coronary Stent System
Receives: Device: Cinatra™ Corolimus Eluting Coronary Stent System

What is being measured

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

  1. In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA).

    Measured: 6 months post treatment

Secondary outcomes (13)

  1. Target lesion revascularization

    Measured: 1, 6 and 18 month and annually to 5 years

  2. Target vessel revascularization

    Measured: 1 month and at all follow up to 5 years

  3. Stent thrombosis

    Measured: All follow ups

  4. Neointimal Hyperplasia

    Measured: 6 and 18 months

  5. Binary restenosis

    Measured: 6 and 18 months

  6. MACE (Major Adverse Cardiac Event)

    Measured: 1 month, 6 month, 18 month and annually to 5 years

  7. In-segment late lumen loss (LLL) as measured by quantitative coronary angiography

    Measured: 6 and 18 months

  8. In-stent late lumen loss (LLL) as measured by quantitative coronary angiography

    Measured: 18 months (optional)

  9. Minimal Lumen Diameter (MLD), in-stent and in-segment

    Measured: 6 and 18 months

  10. Rates of incomplete stent apposition

    Measured: 6 and 18 months

  11. Device success defined as achievement of a final residual diameter stenosis of < 30% measured by QCA, using the study device only.

    Measured: procedure

  12. Lesion treatment success is defined as <30% residual stenosis measured by QCA by any treatment

    Measured: Procedure

  13. Procedure success defined as lesion success without the occurrence of MACE during the hospital stay

    Measured: discharge

Timeline

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

  1. First posted4 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionNov 2010
  4. Study completionMar 2012

Why it stopped: Terminated following completion of 2 year time point: Sponsor decision

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025869
Sponsor's protocol ID
902
Acronym
VANTAGE-1
Status last verified
Jan 2016
First submitted
3 Dec 2009
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cinatra™ Corolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Atrium Medical Corporation at 4 sites in New Zealand.

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 18 inclusion and 27 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: stopped early, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand. 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.

Are results available for this study?

The study was stopped early (reason given: Terminated following completion of 2 year time point: Sponsor decision). 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?

In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA). (time frame: 6 months post treatment). 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 NCT01025869.

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 12 Jan 2016.

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