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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00148356




Registration number
NCT00148356
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
1/04/2011

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 Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions
Secondary ID [1] 0 0
640-0047
Universal Trial Number (UTN)
Trial acronym
ZoMaxx™ I
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 System

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 System
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 end-point is in-segment late-loss at 9 months (as measured by QCA), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Target Lesion revascularization(TLR)
Timepoint [1] 0 0
at 9 months
Secondary outcome [2] 0 0
Target Vessel Revascularization (TVR)
Timepoint [2] 0 0
at 9 months
Secondary outcome [3] 0 0
Target Vessel Failure
Timepoint [3] 0 0
at 9 months
Secondary outcome [4] 0 0
Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR
Timepoint [4] 0 0
at 30 days, 6,9,12 months and anually through 5 years

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

* Subject is = 18 years old.
* Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
* Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment.
* Subject is an acceptable candidate for CABG.
* Subject has clinical evidence of ischemic heart disease or a positive functional study.
* Subject has documented stable angina pectoris
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:

* Evidence of an acute myocardial infarction (AMI) or CK-MB > 2x upper limit of normal within 72 hours of the intended treatment (refer to WHO definition).
* Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to ABT-578 (i.e. tacrolimus, sirolimus, everolimus).
* A platelet count < 100 x 109/L or > 700 x 109/L (< 100,000 cells/mm3 or > 700,000 cells/mm3); a WBC < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl.
* Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
* Subject has had any previous or planned brachytherapy in the target vessel.
* Target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.

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
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [2] 0 0
Monash Medical Center - Victoria
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3168 - Victoria
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
Denmark
State/province [6] 0 0
Århus
Country [7] 0 0
France
State/province [7] 0 0
Ollioules
Country [8] 0 0
France
State/province [8] 0 0
Saint-Denis
Country [9] 0 0
France
State/province [9] 0 0
Toulouse, Cedex 9
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
France
State/province [11] 0 0
Tours
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Krozingen
Country [13] 0 0
Germany
State/province [13] 0 0
Dortmund
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Germany
State/province [16] 0 0
Leipzig
Country [17] 0 0
Germany
State/province [17] 0 0
Munich
Country [18] 0 0
Germany
State/province [18] 0 0
Siegburg
Country [19] 0 0
Netherlands
State/province [19] 0 0
Rotterdam
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Dunedin
Country [22] 0 0
Portugal
State/province [22] 0 0
Carnaxide
Country [23] 0 0
Switzerland
State/province [23] 0 0
Kreuzlingen
Country [24] 0 0
Switzerland
State/province [24] 0 0
Meyrin-Geneva
Country [25] 0 0
Switzerland
State/province [25] 0 0
Zürich
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

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/study/NCT00148356
Trial related presentations / publications
Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus- versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries The ZoMaxx I trial. JACC Cardiovasc Interv. 2008 Oct;1(5):524-32. doi: 10.1016/j.jcin.2008.08.010.
Public notes

Contacts
Principal investigator
Name 0 0
Bernard Chevalier, M.D.
Address 0 0
Centre Cardiologique du Nord
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/study/NCT00148356