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 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.
at 9 months

Secondary Outcomes (1)

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.
at 9 months

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

Interventions

ZoMaxx™ Drug-Eluting Coronary Stent SystemDevice

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

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary StentDevice

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

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (92)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

ACS-Mesa General Hospital

Gilbert, Arizona, 85233, United States

Foundation for Cardiovascular Medicine

La Jolla, California, 92037, United States

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Sequoia Hospital

Redwood City, California, 94062, United States

Stanford University Medical Center

Stanford, California, 94305, United States

University of Colorado

Denver, Colorado, 80262, United States

Related Publications (1)

Gray WA, Yeung AC, Cutlip DE, Popma JJ, Fitzgerald PJ, Williams DO, Heuer H, O'Shaughnessy CD, Overlie PA, Mann JT, Cannon LA, Hermiller JB, Henry TD, Whitbourn R, Stuckey TD, Midei MG, Coe J, Schwartz LB. A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: final results of the ZoMaxx II trial. Int J Cardiol. 2012 May 17;157(1):96-101. doi: 10.1016/j.ijcard.2011.05.061. Epub 2011 Jun 11.
PMID: 21658783DERIVED

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary RestenosisVascular DiseasesMyocardial IschemiaCoronary Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

Alan Yeung, M.D.
Stanford University
PRINCIPAL INVESTIGATOR
David Lee, M.D.
Stanford University
STUDY DIRECTOR

Enrollment

1,099 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

May 2005

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 (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (92)

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 (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (92)

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