The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries (VANTAGE 1)

This study has been terminated.
(Terminated ahead of schedule after completion of the 2-year follow-up time point due to Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT01025869
First received: December 3, 2009
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Coronary Artery Disease
Device: Cinatra™ Corolimus Eluting Coronary Stent System

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

Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA). [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target lesion revascularization [ Time Frame: 1, 6 and 18 month and annually to 5 years ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 1 month and at all follow up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: All follow ups ] [ Designated as safety issue: Yes ]
  • Neointimal Hyperplasia [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
  • Binary restenosis [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
  • MACE (Major Adverse Cardiac Event) [ Time Frame: 1 month, 6 month, 18 month and annually to 5 years ] [ Designated as safety issue: Yes ]
  • In-segment late lumen loss (LLL) as measured by quantitative coronary angiography [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
  • In-stent late lumen loss (LLL) as measured by quantitative coronary angiography [ Time Frame: 18 months (optional) ] [ Designated as safety issue: No ]
  • Minimal Lumen Diameter (MLD), in-stent and in-segment [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
  • Rates of incomplete stent apposition [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
  • Device success defined as achievement of a final residual diameter stenosis of < 30% measured by QCA, using the study device only. [ Time Frame: procedure ] [ Designated as safety issue: No ]
  • Lesion treatment success is defined as <30% residual stenosis measured by QCA by any treatment [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Procedure success defined as lesion success without the occurrence of MACE during the hospital stay [ Time Frame: discharge ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cinatra™ Corolimus Eluting Coronary Stent System
    Stent implantation
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.

  Eligibility

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

Inclusion Criteria:

  1. Patient is ≥ 18 years old
  2. Patient is an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
  3. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
  4. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
  5. 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
  6. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed

Angiographic:

  1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
  2. 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
  3. Target lesion must be a de novo lesion in native coronary artery
  4. Target lesion must be ≤ 22 mm in length
  5. Target lesion must have a stenosis of ≥ 50% and < 100%
  6. Target vessel must have a reference vessel diameter (RVD) appropriate for treatment with a of 3.0mm or3.5 mm stent
  7. Target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2

Exclusion Criteria:

  1. 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
  2. History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  3. 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
  4. Serum creatinine level 170 micromol/L within 7 days prior to index procedure
  5. 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)
  6. Previous PCI of the target vessel within 9 months prior to the procedure
  7. Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
  8. 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.)
  9. 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
  10. History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  12. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  13. Concurrent medical condition with a life expectancy of less than 12 months
  14. 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:

  1. 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
  2. Previous stenting in the target vessel.
  3. The target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA
  4. The target vessel has evidence of thrombus
  5. The target vessel is excessively tortuous (two bends > 90º to reach the target lesion)
  6. 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
  7. Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)
  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: NCT01025869

Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand
Mercy Angiography
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
Principal Investigator: John Ormiston, MD Associate Professor and Interventional Cardiologist at Auckland City Hospital
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT01025869     History of Changes
Other Study ID Numbers: 902
Study First Received: December 3, 2009
Last Updated: April 16, 2013
Health Authority: New Zealand: Health and Disability Ethics Committees

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014