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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00140101

Collaborator

(none)

1,099

Enrollment

Locations

Arms

Duration (Months)

11.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis	Device: ZoMaxx™ Drug-Eluting Coronary Stent System Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1099 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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 Start Date :

May 1, 2005

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ZoMaxx™ Drug-Eluting Stent System	Device: ZoMaxx™ Drug-Eluting Coronary Stent System Drug eluting stent implantation stent in the treatment of coronary artery disease.
Active Comparator: 2 TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System	Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.

Arm

Intervention/Treatment

Experimental: 1

ZoMaxx™ Drug-Eluting Stent System

Device: ZoMaxx™ Drug-Eluting Coronary Stent System

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

Active Comparator: 2

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

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

Outcome Measures

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. [at 9 months]

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. [at 9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsville Hospital	Huntsville	Alabama	United States	35801
2	ACS-Mesa General Hospital	Gilbert	Arizona	United States	85233
3	Foundation for Cardiovascular Medicine	La Jolla	California	United States	92037
4	Scripps Memorial Hospital	La Jolla	California	United States	92037
5	Sequoia Hospital	Redwood City	California	United States	94062
6	Stanford University Medical Center	Stanford	California	United States	94305
7	University of Colorado	Denver	Colorado	United States	80262
8	Hartford Hospital	Hartford	Connecticut	United States	06102
9	Washington Hospital Center	Washington	District of Columbia	United States	20010
10	University of Florida Health Science Center	Gainesville	Florida	United States	32610
11	Univ of Florida Health Science Center Shands	Jacksonville	Florida	United States	32209
12	Florida Hospital	Orlando	Florida	United States	32803
13	Morton Plant Hospital	Safety Harbor	Florida	United States	34695
14	Emory Crawford Long Hospital	Atlanta	Georgia	United States	30308
15	Piedmont Hospital	Atlanta	Georgia	United States	30309
16	Emory Hospital	Atlanta	Georgia	United States	30322
17	St. Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
18	NE Georgia Medical Center	Gainesville	Georgia	United States	30501
19	Medical Center of Central GA (MCCG)	Macon	Georgia	United States	31201
20	Rush University Medical Center	Chicago	Illinois	United States	60612
21	OSF St. Francis Medical Center	Peoria	Illinois	United States	61614
22	St. John's Hospital and Memorial Medical Center	Springfield	Illinois	United States	62701
23	Clarion Health/Methodist Hospital	Indianapolis	Indiana	United States	46202
24	The Heart Center of IN, LLC	Indianapolis	Indiana	United States	46290
25	Genesis Medical Center	Davenport	Iowa	United States	52803
26	Iowa Heart Center/Methodist Hospital	Des Moines	Iowa	United States	50309
27	University of Iowa Hospital	Iowa City	Iowa	United States	52242-1081
28	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
29	Central Baptist Hospital	Lexington	Kentucky	United States	40503
30	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
31	St. Joseph Medical Center	Towson	Maryland	United States	21204
32	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
33	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
34	Cape Cod Research Institute	Hyannis	Massachusetts	United States	02601
35	St. John's Hospital	Detroit	Michigan	United States	48236
36	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
37	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
38	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
39	Baptist Hospital Desoto	Southaven	Mississippi	United States	38761
40	Barnes Jewish Hospital	St. Louis	Missouri	United States	63110
41	Our Lady of Lourdes Medical Center	Cherry Hill	New Jersey	United States	08103
42	St. Joseph's Hospital Health Center	Liverpool	New York	United States	13088
43	New York Presbyterian Hospital-Cornell	New York City	New York	United States	10021
44	Lenox Hill Hospital	New York	New York	United States	10021
45	Columbia Presbyterian Hospital	New York	New York	United States	10032
46	St. Francis Hospital	Roslyn	New York	United States	11576
47	Novant Medical Group	Charlotte	North Carolina	United States	28204
48	Moses H. Cone Memorial Hospital	Greensboro	North Carolina	United States	27401
49	Wake Medical Hospital	Raleigh	North Carolina	United States	27610
50	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
51	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
52	Aultman Health Foundation	Canton	Ohio	United States	44710
53	The Christ Hospital	Cincinnati	Ohio	United States	45219
54	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
55	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
56	EMH Regional Medical Center	Elyria	Ohio	United States	44035
57	Oklahoma Heart	Oklahoma City	Oklahoma	United States	73120
58	Pinnacle Health at Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17110
59	Hahnemann University Hospital Drexel University	Philadelphia	Pennsylvania	United States	19107
60	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
61	Univ of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania	United States	15213
62	Holy Spirit Hospital	Wormleysburg	Pennsylvania	United States	17043
63	Medical University of South Carolina (MUSC)	Charleston	South Carolina	United States	29425
64	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
65	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
66	Lubbock Heart Hospital	Lubbock	Texas	United States	79410
67	Intermountain Medical Center	Salt Lake City	Utah	United States	84103
68	Inova Fairfax Hospital	Falls Church	Virginia	United States	22031
69	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
70	North Cascade Cardiology / St. Joseph's Hospital	Bellingham	Washington	United States	98225
71	Swedish Medical Center	Seattle	Washington	United States	98104
72	Deaconess Medical Center	Spokane	Washington	United States	99204
73	Heart Clinics Northwest/ Sacred Heart Medical Center	Spokane	Washington	United States	99204
74	St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
75	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales	Australia	2010
76	Eastern Heart Clinic, The Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
77	The Prince Charles Hospital	Chermside	Queensland	Australia	4061
78	The Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4109
79	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
80	Monash Medical Center - Cardiovascular Research Centre	Clayton	Victoria	Australia	03168-
81	St. Vincent's Hospital	Fitzroy		Australia	3065
82	Liverpool Hospital	New South Wales		Australia	2170
83	RWTH Aachen	Aachen		Germany	52074-
84	Charité - Campus Benjamin Franklin	Berlin		Germany
85	St.Johannes Krankenhaus	Dortmund		Germany	44137
86	UKE Hamburg - Universitätsklinikum Eppendorf	Hamburg		Germany	20251-
87	Uniklinik Homburg	Homburg		Germany	66421
88	Leipzig Heart Center	Leipzig		Germany	04289
89	Uniklinik Mainz - Johannes Gutenberg Universitat	Mainz		Germany	55131-
90	Krankenhaus Siegburg - Heart Center Siegburg	Siegburg		Germany	53721
91	Auckland City Hospital	Auckland		New Zealand	1003
92	Christchurch Hospital	Christchurch		New Zealand