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

Primary Purpose

Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZoMaxx™ Drug-Eluting Coronary Stent System
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Huntsville Hospital
  • ACS-Mesa General Hospital
  • Foundation for Cardiovascular Medicine
  • Scripps Memorial Hospital
  • Sequoia Hospital
  • Stanford University Medical Center
  • University of Colorado
  • Hartford Hospital
  • Washington Hospital Center
  • University of Florida Health Science Center
  • Univ of Florida Health Science Center Shands
  • Florida Hospital
  • Morton Plant Hospital
  • Emory Crawford Long Hospital
  • Piedmont Hospital
  • Emory Hospital
  • St. Joseph's Hospital of Atlanta
  • NE Georgia Medical Center
  • Medical Center of Central GA (MCCG)
  • Rush University Medical Center
  • OSF St. Francis Medical Center
  • St. John's Hospital and Memorial Medical Center
  • Clarion Health/Methodist Hospital
  • The Heart Center of IN, LLC
  • Genesis Medical Center
  • Iowa Heart Center/Methodist Hospital
  • University of Iowa Hospital
  • University of Kansas Medical Center
  • Central Baptist Hospital
  • Ochsner Clinic Foundation
  • St. Joseph Medical Center
  • Brigham & Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Cape Cod Research Institute
  • St. John's Hospital
  • Northern Michigan Hospital
  • William Beaumont Hospital
  • Abbott Northwestern Hospital
  • Baptist Hospital Desoto
  • Barnes Jewish Hospital
  • Our Lady of Lourdes Medical Center
  • St. Joseph's Hospital Health Center
  • New York Presbyterian Hospital-Cornell
  • Lenox Hill Hospital
  • Columbia Presbyterian Hospital
  • St. Francis Hospital
  • Novant Medical Group
  • Moses H. Cone Memorial Hospital
  • Wake Medical Hospital
  • Forsyth Medical Center
  • Wake Forest University Baptist Medical Center
  • Aultman Health Foundation
  • The Christ Hospital
  • Cleveland Clinic Foundation
  • Riverside Methodist Hospital
  • EMH Regional Medical Center
  • Oklahoma Heart
  • Pinnacle Health at Harrisburg Hospital
  • Hahnemann University Hospital Drexel University
  • Thomas Jefferson University Hospital
  • Univ of Pittsburgh Medical Center Health System
  • Holy Spirit Hospital
  • Medical University of South Carolina (MUSC)
  • Erlanger Medical Center
  • St. Luke's Episcopal Hospital
  • Lubbock Heart Hospital
  • Intermountain Medical Center
  • Inova Fairfax Hospital
  • Overlake Hospital Medical Center
  • North Cascade Cardiology / St. Joseph's Hospital
  • Swedish Medical Center
  • Deaconess Medical Center
  • Heart Clinics Northwest/ Sacred Heart Medical Center
  • St. Luke's Medical Center
  • St. Vincent's Hospital Sydney
  • Eastern Heart Clinic, The Prince of Wales Hospital
  • The Prince Charles Hospital
  • The Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Monash Medical Center - Cardiovascular Research Centre
  • St. Vincent's Hospital
  • Liverpool Hospital
  • RWTH Aachen
  • Charité - Campus Benjamin Franklin
  • St.Johannes Krankenhaus
  • UKE Hamburg - Universitätsklinikum Eppendorf
  • Uniklinik Homburg
  • Leipzig Heart Center
  • Uniklinik Mainz - Johannes Gutenberg Universitat
  • Krankenhaus Siegburg - Heart Center Siegburg
  • Auckland City Hospital
  • Christchurch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

ZoMaxx™ Drug-Eluting Stent System

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 30, 2005
Last Updated
January 6, 2012
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00140101
Brief Title
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
Acronym
ZoMaxx™ II
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Coronary artery disease is the major cause of morbidity and mortality in the United States. The American Heart Association estimates that 571,000 Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures were performed in 2001 in the United States and that 80% to 90% of these patients also underwent stent placement. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 to 35% in-stent restenosis occurs within 6 to 9 months after stent placement. While stents can reduce restenosis by blocking vascular recoil and remodeling, mechanical intervention alone is incapable of treating the biological problem of neointimal hyperplasia. Various approaches have been used to treat in-stent restenosis, including balloon angioplasty, repeat stenting, rotational and directional atherectomy, laser, and local delivery of radiation at the time of stenting (brachytherapy). However, these techniques add complexity to the interventional procedure and have not had documented success in preventing in-stent restenosis. Drug-eluting stents (DES) using antiproliferative agents delivered via a polymer based stent platform have shown significant success in the reduction of restenosis in de novo lesions over the traditional bare metal stents in randomized clinical trials. Local delivery of the pharmacological agent allows for controlled delivery of high drug concentrations to the targeted tissue while minimizing systemic drug effects. The ZoMaxx II Trial represents the first US study of the ZoMaxx(TM) Drug Eluting Coronary Stent System to evaluate the potential benefits of the local application of the zotarolimus drug in combination with a phosphorylcholine (PC)-coated tri-metal stent. ZoMaxx™ Drug-Eluting Stent System is an Investigational device. Limited by Federal (U.S.) law to investigational use only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1099 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ZoMaxx™ Drug-Eluting Stent System
Arm Title
2
Arm Type
Active Comparator
Arm Description
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
ZoMaxx™ Drug-Eluting Coronary Stent System
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Intervention Type
Device
Intervention Name(s)
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Intervention Description
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Primary Outcome Measure Information:
Title
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.
Time Frame
at 9 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
at 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Yeung, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Lee, M.D.
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
ACS-Mesa General Hospital
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85233
Country
United States
Facility Name
Foundation for Cardiovascular Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Univ of Florida Health Science Center Shands
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Morton Plant Hospital
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Emory Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
NE Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Medical Center of Central GA (MCCG)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
St. John's Hospital and Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Clarion Health/Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Heart Center of IN, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Iowa Heart Center/Methodist Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1081
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cape Cod Research Institute
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
St. John's Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Baptist Hospital Desoto
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38761
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Joseph's Hospital Health Center
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
New York Presbyterian Hospital-Cornell
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Novant Medical Group
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Wake Medical Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
EMH Regional Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Oklahoma Heart
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Hahnemann University Hospital Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Holy Spirit Hospital
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lubbock Heart Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
North Cascade Cardiology / St. Joseph's Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Heart Clinics Northwest/ Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Eastern Heart Clinic, The Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4061
Country
Australia
Facility Name
The Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4109
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Center - Cardiovascular Research Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
03168-
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Liverpool Hospital
City
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
RWTH Aachen
City
Aachen
ZIP/Postal Code
52074-
Country
Germany
Facility Name
Charité - Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
St.Johannes Krankenhaus
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
UKE Hamburg - Universitätsklinikum Eppendorf
City
Hamburg
ZIP/Postal Code
20251-
Country
Germany
Facility Name
Uniklinik Homburg
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Leipzig Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Uniklinik Mainz - Johannes Gutenberg Universitat
City
Mainz
ZIP/Postal Code
55131-
Country
Germany
Facility Name
Krankenhaus Siegburg - Heart Center Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1003
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
21658783
Citation
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.
Results Reference
derived

Learn more about this trial

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

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