- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025869
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries (VANTAGE-1)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Auckland, New Zealand
- Auckland City Hospital
-
Auckland, New Zealand
- North Shore Hospital
-
Auckland, New Zealand
- Mercy Angiography
-
Christchurch, New Zealand
- Christchurch Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stent System
Cinatra™ Corolimus Eluting Coronary Stent System
|
Stent implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA).
Time Frame: 6 months post treatment
|
6 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Target lesion revascularization
Time Frame: 1, 6 and 18 month and annually to 5 years
|
1, 6 and 18 month and annually to 5 years
|
Target vessel revascularization
Time Frame: 1 month and at all follow up to 5 years
|
1 month and at all follow up to 5 years
|
Stent thrombosis
Time Frame: All follow ups
|
All follow ups
|
Neointimal Hyperplasia
Time Frame: 6 and 18 months
|
6 and 18 months
|
Binary restenosis
Time Frame: 6 and 18 months
|
6 and 18 months
|
MACE (Major Adverse Cardiac Event)
Time Frame: 1 month, 6 month, 18 month and annually to 5 years
|
1 month, 6 month, 18 month and annually to 5 years
|
In-segment late lumen loss (LLL) as measured by quantitative coronary angiography
Time Frame: 6 and 18 months
|
6 and 18 months
|
In-stent late lumen loss (LLL) as measured by quantitative coronary angiography
Time Frame: 18 months (optional)
|
18 months (optional)
|
Minimal Lumen Diameter (MLD), in-stent and in-segment
Time Frame: 6 and 18 months
|
6 and 18 months
|
Rates of incomplete stent apposition
Time Frame: 6 and 18 months
|
6 and 18 months
|
Device success defined as achievement of a final residual diameter stenosis of < 30% measured by QCA, using the study device only.
Time Frame: procedure
|
procedure
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Lesion treatment success is defined as <30% residual stenosis measured by QCA by any treatment
Time Frame: Procedure
|
Procedure
|
Procedure success defined as lesion success without the occurrence of MACE during the hospital stay
Time Frame: discharge
|
discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Ormiston, MD, Associate Professor and Interventional Cardiologist at Auckland City Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 902 (Rowett institute code)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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