Coronary DiseasePhase 2/3ZoMaxx™ INCT00148356
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
A Phase 2/3 study testing ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 29 sitesin 10 countries
- Study dates
- Sep 2004to Oct 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
29 sites in 10 countries.
29 sites in 10 countries
Germany7 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
St.Johannes Krankenhaus
Dortmund, 44137
Universitätsklinikum Essen
Essen, 45122
Universitätsklinikum Eppendorf
Hamburg, 20245
Herzzentrum Leipzig
Leipzig, 04289
Cardiology Practice and Hospital Prof. Silber
Munich, 81379
Herzzentrum Siegburg GmbH
Siegburg, 53721
France5 sites
Polyclinique les Fleurs
Ollioules, 83190
Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux
Saint-Denis, 93200
Hôpital de Rangueil - CHU
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
Clinique Saint Gatien
Tours, 37042
Belgium4 sites
Onze Lieve Vrouw Hospital
Aalst, 9300
Middelheim Algemeen Ziekenhuis
Antwerp, 2020
KU Leuven - UZ Gasthuisberg
Leuven, 3000
C.H.U. Sart Tilman
Liège, 4000
Switzerland3 sites
Herzzentrum Bodensee
Kreuzlingen, 8280
La Tour Hospital
Meyrin-Geneva, 1217
University Hospital Zürich
Zurich, 8091
Australia2 sites
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Monash Medical Center
Victoria, 3168
Denmark2 sites
Skejby Sygehus
Aarhus, Aarhus N
Rigshospitalet / University of Copenhagen
Copenhagen, DK-2100
New Zealand2 sites
Auckland City Hospital
Auckland
Dunedin Hospital
Dunedin
United Kingdom2 sites
Barts and the London NHS Trust
London, E2 9JX
Royal Brompton Hospital
London, SW36NP
About this study
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
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.
Read the 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.
- Being tested
- ZoMaxx™ Drug-Eluting Coronary Stent System, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
- Keywords
- drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoMaxx™ Drug-Eluting Coronary Stent SystemDevice
Drug eluting stent implantation stent in the treatment of coronary artery disease.
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemDevice
Drug eluting stent implantation stent in the treatment of coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ZoMaxx™ Drug-Eluting Stent System Receives: Device: ZoMaxx™ Drug-Eluting Coronary Stent System |
| 2 | Active comparator | TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System Receives: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (4)
Target Lesion revascularization(TLR)
Measured: at 9 months
Target Vessel Revascularization (TVR)
Measured: at 9 months
Target Vessel Failure
Measured: at 9 months
Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR
Measured: at 30 days, 6,9,12 months and anually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2006
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard Chevalier, M.D., Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148356
- Sponsor's protocol ID
- 640-0047
- Acronym
- ZoMaxx™ I
- Status last verified
- Mar 2011
- First submitted
- 6 Sep 2005
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. 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 Cardiovasc Interv. 2008 Oct;1(5):524-32. doi: 10.1016/j.jcin.2008.08.010.
PubMed 19463354
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00148356
- Acronym / sponsor ID
- ZoMaxx™ I / 640-0047
- Keywords
- drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ZoMaxx™ Drug-Eluting Coronary Stent SystemZoMaxx™ Drug-Eluting Stent System |
| 2 | Active comparator | Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemTAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoMaxx™ Drug-Eluting Coronary Stent SystemDrug eluting stent implantation stent in the treatment of coronary artery disease. | Device | 1 |
| TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent SystemDrug eluting stent implantation stent in the treatment of coronary artery disease. | Device | 2 |
Primary outcome
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
4 secondary outcomes
Target Lesion revascularization(TLR)
Time frame: at 9 months
Target Vessel Revascularization (TVR)
Time frame: at 9 months
Target Vessel Failure
Time frame: at 9 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
- Results publication: PubMed 19463354Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. 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 Cardiovasc Interv. 2008 Oct;1(5):524-32. doi: 10.1016/j.jcin.2008.08.010.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Chevalier, M.D. principal investigator
Centre Cardiologique du Nord
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 29 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, France, Belgium, Switzerland, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.