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

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00148356
First received: September 6, 2005
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Target Lesion revascularization(TLR) [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Failure [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
  • Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR [ Time Frame: at 30 days, 6,9,12 months and anually through 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 401
Study Start Date: September 2004
Study Completion Date: October 2010
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148356

  Show 29 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Bernard Chevalier, M.D. Centre Cardiologique du Nord
  More Information

Publications:
Bernard Chevalier, MD., et. al. 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: Cardiovascular Interventions. 1(5):524-32, 2008.

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00148356     History of Changes
Other Study ID Numbers: 640-0047
Study First Received: September 6, 2005
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Abbott Vascular:
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014