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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00148356

Collaborator

(none)

401

Enrollment

Locations

Arms

Duration (Months)

13.8

Patients Per Site

0.2

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 System	Phase 2/Phase 3

Detailed Description

Heart disease is the leading cause of death in Europe as a whole, and while mortality rates for cardiovascular disease have decreased in most western European countries, due to expanded use of prevention strategies and better treatment, coronary heart disease mortality in the middle age groups is increasing rapidly in most of the countries in Eastern Europe. The number of procedures performed to treat cardiovascular disease in Europe is constantly increasing, although different types of procedures are exhibiting different trends. Percutaneous coronary interventions (PCI) procedures, for example, totaled 430,000 in the European Union (15 countries) and 520,000 in Europe as a whole (33 countries) in 2000, as reported by the Euro Heart Survey, and growth is continuing at a rate of more than 20% per year. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 - 35% of 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 use 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 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 maximizing systemic drug effects. The ZoMaxx I Trial is a study of the ZoMaxx Drug Eluting Coronary Stent System (ZoMaxx DES) 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 :

401 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

Oct 1, 2010

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 System 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 System

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

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.
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

Exclusion Criteria include all of the following:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Vincent's Hospital	Fitzroy	Victoria	Australia	3065
2	Monash Medical Center	Victoria		Australia	3168
3	Onze Lieve Vrouw Hospital	Aalst		Belgium	9300
4	Middelheim Algemeen Ziekenhuis	Antwerpen		Belgium	2020
5	KU Leuven - UZ Gasthuisberg	Leuven		Belgium	3000
6	C.H.U. Sart Tilman	Liège		Belgium	4000
7	Rigshospitalet / University of Copenhagen	Copenhagen		Denmark	DK-2100
8	Skejby Sygehus	Århus		Denmark	Aarhus N
9	Polyclinique les Fleurs	Ollioules		France	83190
10	Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux	Saint-Denis		France	93200
11	Hôpital de Rangueil - CHU	Toulouse, Cedex 9		France	31059
12	Clinique Pasteur	Toulouse		France	31076
13	Clinique Saint Gatien	Tours		France	37042
14	Herzzentrum Bad Krozingen	Bad Krozingen		Germany	79189
15	St.Johannes Krankenhaus	Dortmund		Germany	44137
16	Universitätsklinikum Essen	Essen		Germany	45122
17	Universitätsklinikum Eppendorf	Hamburg		Germany	20245
18	Herzzentrum Leipzig	Leipzig		Germany	04289
19	Cardiology Practice and Hospital Prof. Silber	Munich		Germany	81379
20	Herzzentrum Siegburg GmbH	Siegburg		Germany	53721
21	Erasmus Medical Center	Rotterdam		Netherlands	3015 CE
22	Auckland City Hospital	Auckland		New Zealand
23	Dunedin Hospital	Dunedin		New Zealand
24	Hospital de Santa Cruz	Carnaxide		Portugal	2790-134
25	Herzzentrum Bodensee	Kreuzlingen		Switzerland	8280
26	La Tour Hospital	Meyrin-Geneva		Switzerland	1217
27	University Hospital Zürich	Zürich		Switzerland	8091
28	Barts and the London NHS Trust	London		United Kingdom	E2 9JX
29	Royal Brompton Hospital	London		United Kingdom	SW36NP