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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01025869




Registration number
NCT01025869
Ethics application status
Date submitted
3/12/2009
Date registered
4/12/2009
Date last updated
12/01/2016

Titles & IDs
Public title
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Scientific title
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Secondary ID [1] 0 0
902
Universal Trial Number (UTN)
Trial acronym
VANTAGE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cinatra™ Corolimus Eluting Coronary Stent System

Other: Stent System - Cinatra™ Corolimus Eluting Coronary Stent System


Treatment: Devices: Cinatra™ Corolimus Eluting Coronary Stent System
Stent implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA).
Timepoint [1] 0 0
6 months post treatment
Secondary outcome [1] 0 0
Target lesion revascularization
Timepoint [1] 0 0
1, 6 and 18 month and annually to 5 years
Secondary outcome [2] 0 0
Target vessel revascularization
Timepoint [2] 0 0
1 month and at all follow up to 5 years
Secondary outcome [3] 0 0
Stent thrombosis
Timepoint [3] 0 0
All follow ups
Secondary outcome [4] 0 0
Neointimal Hyperplasia
Timepoint [4] 0 0
6 and 18 months
Secondary outcome [5] 0 0
Binary restenosis
Timepoint [5] 0 0
6 and 18 months
Secondary outcome [6] 0 0
MACE (Major Adverse Cardiac Event)
Timepoint [6] 0 0
1 month, 6 month, 18 month and annually to 5 years
Secondary outcome [7] 0 0
In-segment late lumen loss (LLL) as measured by quantitative coronary angiography
Timepoint [7] 0 0
6 and 18 months
Secondary outcome [8] 0 0
In-stent late lumen loss (LLL) as measured by quantitative coronary angiography
Timepoint [8] 0 0
18 months (optional)
Secondary outcome [9] 0 0
Minimal Lumen Diameter (MLD), in-stent and in-segment
Timepoint [9] 0 0
6 and 18 months
Secondary outcome [10] 0 0
Rates of incomplete stent apposition
Timepoint [10] 0 0
6 and 18 months
Secondary outcome [11] 0 0
Device success defined as achievement of a final residual diameter stenosis of < 30% measured by QCA, using the study device only.
Timepoint [11] 0 0
procedure
Secondary outcome [12] 0 0
Lesion treatment success is defined as <30% residual stenosis measured by QCA by any treatment
Timepoint [12] 0 0
Procedure
Secondary outcome [13] 0 0
Procedure success defined as lesion success without the occurrence of MACE during the hospital stay
Timepoint [13] 0 0
discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atrium Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01025869
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Ormiston, MD
Address 0 0
Associate Professor and Interventional Cardiologist at Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01025869