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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/NCT00606333




Registration number
NCT00606333
Ethics application status
Date submitted
17/01/2008
Date registered
1/02/2008
Date last updated
25/10/2012

Titles & IDs
Public title
Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions
Scientific title
A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution Versus the TAXUS Liberte Paclitaxel-eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
CP-06
Universal Trial Number (UTN)
Trial acronym
NEVO RES-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NEVO™ Sirolimus-eluting Coronary Stent System
Treatment: Devices - Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)

Experimental: Investigational arm - Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.

Active Comparator: Control Arm - Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.


Treatment: Devices: NEVO™ Sirolimus-eluting Coronary Stent System
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.

Treatment: Devices: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Angiographic endpoint of in-stent late lumen loss as measured by QCA.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Target Lesion Failure defined as cardiac death that cannot be clearly attributed to a non-cardiac event or non-target vessel, target vessel related myocardial infarction or clinically driven target lesion revascularization.
Timepoint [1] 0 0
hospital discharge, 30 days, 6 months and annually through five years.
Secondary outcome [2] 0 0
Target Vessel Failure defined as any myocardial infarction or cardiac death that cannot be attributed to a non-target vessel or any target vessel revascularization.
Timepoint [2] 0 0
Hospital discharge, 30 days, 6 months and annually through five years
Secondary outcome [3] 0 0
Major Adverse Cardiac Events defined as an adjudicated composite of death, emergent coronary artery bypass graft surgery, target lesion revascularization, or new myocardial infarction.
Timepoint [3] 0 0
Hospital discharge, 30 days, 6 months and annually through five years
Secondary outcome [4] 0 0
Incidence of stent thrombosis
Timepoint [4] 0 0
Hospital discharge, 30 days, 6 months and annually through five years
Secondary outcome [5] 0 0
Incidence of target lesion revascularization and target vessel revascularization.
Timepoint [5] 0 0
Hospital discharge, 30 days, 6 months and annually through five years
Secondary outcome [6] 0 0
Device Success
Timepoint [6] 0 0
Procedural
Secondary outcome [7] 0 0
Lesion success
Timepoint [7] 0 0
Procedural
Secondary outcome [8] 0 0
Procedure Success
Timepoint [8] 0 0
Hospital Discharge
Secondary outcome [9] 0 0
Angiographic in-stent and in-segment binary restenosis.
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
In-stent minimum lumen diameter
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Percent volume obstruction of the stent by intravascular ultrasound evaluation
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Patient reported outcomes as measured by three standardized quality of life surveys.
Timepoint [12] 0 0
Baseline, 30 days, 6 months and 12 months

Eligibility
Key inclusion criteria
- 18 years of age or older

- Eligible for percutaneous coronary intervention and coronary artery bypass graft
surgery.

- Diagnosis of stable or unstable angina or silent ischemia

- Left ventricular ejection fraction >30%

- The subject requires treatment of a single de novo lesion in a native coronary artery.

- Lesion to be treated is less than or equal to 28 mm in length in a vessel that is
2.5-3.5mm diameter.

- The target lesion diameter stenosis is >50% and <100% by visual estimate.

- The target lesion is a minimum of 10 mm distance from any previously treated segment
of the target vessel.

- The subject understands the study requirements, is willing to comply with all study
procedures and has provided written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- The subject has undergone coronary revascularization to any vessel within 30 days.

- The subject has undergone target vessel revascularization within 6 months.

- Treatment of more than one qualifying lesion is required at the time of enrollment, or
is planned within 30 days following enrollment.

- The subject has known sensitivity to sirolimus, paclitaxel, the polymeric matrices,
stainless steel or cobalt chromium.

- There is planned treatment of the target lesion with any device other than the
pre-dilatation balloon angioplasty catheter.

- The subject had a myocardial infarction within 72 hours, or presents with CK elevation
> 2 times upper limit normal associated with elevated CK-MB.

- The subject is in cardiogenic shock.

- The subject had a cerebrovascular accident within the past 6 months.

- The subject has acute or chronic renal dysfunction (defined as creatinine >2.0 mg/dl).

- The subject has a contraindication to aspirin or clopidogrel.

- The subject has thrombocytopenia (platelet count < 100,000/mm3.

- The subject has had active gastrointestinal bleeding within the past 3 months.

- The subject has a known bleeding or hypercoagulable disorder.

- The subject has had prior anaphylactoid reaction to contrast agents or has contrast
sensitivity that cannot be controlled with pre-medication.

- The subject is currently taking immunosuppressant therapy.

- The subject is currently, or has been treated wtih either Rapamune or paclitaxel
within 12 months of the procedure.

- The subject is a female with a positive pregnancy test or is lactating.

- The subject has an active infection.

- The subject has co-morbidities that could interfere wtih completion of study
procedures, or life expectancy less than 24 months.

- The subject is participating in another investigational drug or device trial that has
not completed the primary endpoint or would interfere with the endpoints of this
study.

Angiographic Exclusion Criteria

- Left main disease >50% diameter stenosis.

- The target lesion is ostial.

- The target lesion or target vessel are severely calcified.

- The target lesion involves a bifurcation with diseased branch vessel greater than or
equal to 2.0 mm that would require intervention or protection.

- The target lesion has TIMI o or TIMI I flow.

- Angiographic evidence of thrombus.

- The target vessel has had prior stent placement.

- The patient has had prior coronary brachytherapy.

- There is angiographic restenosis of any previously treated segment of the target
vessel, or atherosclerotic area wtih >50% diameter stenosis outside of the target
lesion.

- The subject has undergone prior CABG.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
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
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
394
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cordis Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Conor Medsystems
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Conor
Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single
atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of
a new drug-eluting stent compared to an approved drug-eluting stent.

While Cordis made a business decision to no longer pursue NEVO™ development and
commercialization, the patients will be followed up as per protocol. This includes performing
all protocol required follow-up visits and the collection and reporting of all safety
information.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00606333
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Ormiston, MB ChM
Address 0 0
Mercy Angiography Unit
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/NCT00606333