NCT00148356

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
10 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

September 6, 2005

Last Update Submit

March 31, 2011

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary Restenosis

Keywords

drug eluting stentsstentsangioplastycoronary artery diseasetotal coronary occlusioncoronary artery restenosisstent thrombosisvascular diseasemyocardial ischemiacoronary artery stenosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (4)

  • Target Lesion revascularization(TLR)

    at 9 months

  • Target Vessel Revascularization (TVR)

    at 9 months

  • Target Vessel Failure

    at 9 months

  • Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR

    at 30 days, 6,9,12 months and anually through 5 years

Study Arms (2)

1

EXPERIMENTAL

ZoMaxx™ Drug-Eluting Stent System

Device: ZoMaxx™ Drug-Eluting Coronary Stent System

2

ACTIVE COMPARATOR

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Interventions

ZoMaxx™ Drug-Eluting Coronary Stent SystemDEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

1
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemDEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Monash Medical Center

Victoria, 3168, Australia

Location

Onze Lieve Vrouw Hospital

Aalst, 9300, Belgium

Location

Middelheim Algemeen Ziekenhuis

Antwerp, 2020, Belgium

Location

KU Leuven - UZ Gasthuisberg

Leuven, 3000, Belgium

Location

C.H.U. Sart Tilman

Liège, 4000, Belgium

Location

Skejby Sygehus

Aarhus, Aarhus N, Denmark

Location

Rigshospitalet / University of Copenhagen

Copenhagen, DK-2100, Denmark

Location

Polyclinique les Fleurs

Ollioules, 83190, France

Location

Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux

Saint-Denis, 93200, France

Location

Hôpital de Rangueil - CHU

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Clinique Saint Gatien

Tours, 37042, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

St.Johannes Krankenhaus

Dortmund, 44137, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, 20245, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Cardiology Practice and Hospital Prof. Silber

Munich, 81379, Germany

Location

Herzzentrum Siegburg GmbH

Siegburg, 53721, Germany

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

Location

Herzzentrum Bodensee

Kreuzlingen, 8280, Switzerland

Location

La Tour Hospital

Meyrin-Geneva, 1217, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Barts and the London NHS Trust

London, E2 9JX, United Kingdom

Location

Royal Brompton Hospital

London, SW36NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19463354RESULT

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary RestenosisVascular DiseasesMyocardial IschemiaCoronary Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Bernard Chevalier, M.D.

    Centre Cardiologique du Nord

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2006

Study Completion

October 1, 2010

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

FR(5)GB(2)NL(1)BE(4)PT(1)AU(2)DK(2)CH(3)DE(7)NZ(2)