Trials Sponsors Conditions Drugs Pricing

Conditions

Coronary Artery Disease Coronary Disease Coronary 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

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.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemDevice

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

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.

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (29)

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Monash Medical Center

Victoria, 3168, Australia

Onze Lieve Vrouw Hospital

Aalst, 9300, Belgium

Middelheim Algemeen Ziekenhuis

Antwerp, 2020, Belgium

KU Leuven - UZ Gasthuisberg

Leuven, 3000, Belgium

C.H.U. Sart Tilman

Liège, 4000, Belgium

Skejby Sygehus

Aarhus, Aarhus N, Denmark

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

Enrollment

401 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
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 2004

Date type not reported

This date has not been verified as actual or estimated.

Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations