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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/NCT00140101




Registration number
NCT00140101
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
10/01/2012

Titles & IDs
Public title
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
Scientific title
A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System as Compared to the TAXUS™ Express2™ Paclitaxel-Eluting Stent in de Novo Coronary Artery Lesions
Secondary ID [1] 0 0
96039
Secondary ID [2] 0 0
640-0048
Universal Trial Number (UTN)
Trial acronym
ZoMaxx™ II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
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 - ZoMaxx™ Drug-Eluting Coronary Stent System
Treatment: Devices - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Experimental: 1 - ZoMaxx™ Drug-Eluting Stent System

Active Comparator: 2 - TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System


Treatment: Devices: ZoMaxx™ Drug-Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Treatment: Devices: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint is TVR (Target Vessel Revascularization). TVR is defined as any ischemia driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Timepoint [1] 0 0
at 9 months
Secondary outcome [1] 0 0
The major secondary endpoint is in-segment late loss as measured by QCA. In-segment late loss is defined as the difference between the post-procedure minimal luminal diameter (MLD) and the follow-up angiography MLD.
Timepoint [1] 0 0
at 9 months

Eligibility
Key inclusion criteria
Inclusion Criteria include all of the following:

- Subject is = 18 years old

- Subject is eligible for percutaneous coronary intervention (PCI) and has a single
lesion requiring treatment

- Subject is an acceptable candidate for CABG

- Clinical evidence of ischemic heart disease or a positive functional study

- Documented stable angina pectoris

- The target lesion is a single de novo coronary artery lesion with =50 and <100%
stenosis by visual estimate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria include all of the following:

- Female of childbearing potential. Female subjects must be medically or surgically
sterile or diagnosed as post-menopausal (i.e. one year since final menstrual cycle.

- Evidence of an acute myocardial infarction and/or CK-MB>2x upper limit of normal
within 72 hours of the intended treatment

- Known allergies to the following: aspirin, clopidogrel (Plavix) or ticlopidine
(Ticlid), heparin, stainless steel, tantalum, contrast agent (that cannot be
adequately premedicated), paclitaxel or drugs similar to zotarolimus (ABT-578) (i.e.
tacrolimus, sirolimus, everolimus)

- A platelet count <100,000 cells/mm3or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or
hemoglobin <10.0g/dL

- Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150µmol/L)

- Subject has had any previous or planned brachytherapy in the target vessel

Study design
Purpose of the study
Prevention
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
1099
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Eastern Heart Clinic, The Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
The Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Monash Medical Center - Cardiovascular Research Centre - Clayton
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
Liverpool Hospital - New South Wales
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4061 - Chermside
Recruitment postcode(s) [4] 0 0
4109 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
03168- - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
2170 - New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Dortmund
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Germany
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Hamburg
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Germany
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Homburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Siegburg
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New Zealand
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Auckland
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New Zealand
State/province [43] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx
drug-eluting stent in patients with blockage of native coronary arteries. The study is
designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that
has proven superior to bare metal stents and is a recognized standard of care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00140101
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan Yeung, M.D.
Address 0 0
Stanford University
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/NCT00140101