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The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.
This prospective multi-center study has been initiated:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endeavor Zotarolimus Eluting Coronary Stent | Device | Drug eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Cardiac Events) | MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery)) | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Real-world patients requiring drug eluting stent implantation
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| Name | Affiliation | Role |
|---|---|---|
| Ian T Meredith, MD | Monash Medical Centre, Melbourne, Australia | Principal Investigator |
| Chaim Lotan, MD | Hadassah University Hospital, Jerusalem, Israel | Principal Investigator |
| Martin T Rothman, MD | London Chest Hospital, London, United Kingdom | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16908773 | Background | Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14. | |
| 17950836 |
| Label | URL |
|---|---|
| Related Info | View source |
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All enrolled subjects were followed for 12 months. An extended 2-year follow-up was performed in 2116 subjects from 26 centers.
Consecutive patients with an indication for coronary stent implantation according to the Instructions For Use of the Endeavor Coronary Stent, in whom it is an intent to implant one or more Endeavor Coronary Stents should be included (provided patient consent).
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| ID | Title | Description |
|---|---|---|
| FG000 | Endeavor Coronary Stent | Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endeavor Coronary Stent | Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MACE (Major Adverse Cardiac Events) | MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery)) | Intention to Treat (ITT) | Posted | Number | Percentage of participants | 12 Months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endeavor Coronary Stent | Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Death | Cardiac disorders | Systematic Assessment |
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Data collection in this large global registry was limited to MACE (major adverse cardiac events) defined as the composite endpoint of death, myocardial infarction (Q- and non-Q-wave), emergent cardiac bypass surgery and TLR.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sofia Pateraki, MSc - Sr. Clinical Research Specialist | Medtronic Bakken Research Center | +31 43 3566785 | sofia.pateraki@medtronic.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Result |
| Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M. doi: 10.1016/j.amjcard.2007.08.026. |
| 20129549 | Result | Lotan C, Meredith IT, Mauri L, Liu M, Rothman MT; E-Five Investigators. Safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: 12-month data from the E-Five registry. JACC Cardiovasc Interv. 2009 Dec;2(12):1227-35. doi: 10.1016/j.jcin.2009.10.001. |
| 20478863 | Result | Jain AK, Lotan C, Meredith IT, Feres F, Zambahari R, Sinha N, Rothman MT; E-Five Registry Investigators. Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry. Heart. 2010 Jun;96(11):848-53. doi: 10.1136/hrt.2009.184150. |
| 20853351 | Result | Meredith I, Rothman M, Erglis A, Parikh K, Lotan C; E-Five Investigators. Extended follow-up safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: two-year follow-up from the E-Five Registry. Catheter Cardiovasc Interv. 2011 Jun 1;77(7):993-1000. doi: 10.1002/ccd.22803. Epub 2010 Dec 3. |
| 21468534 | Result | Lotan C, Meredith IT, Jain A, Feres F, Firszt A, Garcia AF, Rothman MT. Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent. Arq Bras Cardiol. 2011 May;96(5):353-62. doi: 10.1590/s0066-782x2011005000033. Epub 2011 Apr 1. English, Portuguese, Spanish. |
| 20142198 | Derived | Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138. |
| 17174180 | Derived | Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE; ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes Mellitus | Number | Participants |
|
|
|
| 135 |
| 7,832 |
| 0 |
| 7,832 |
The only disclosure restriction on the PI is that results communications are provided to the sponsor at least 90 days prior to submittal for publication or presentation. The sponsor shall not require changes beyond the extent necessary to allow the sponsor to protect its rights in copyrightable material, and to check for technical correctness.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |