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The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring stent implantation.
A total of 249 to 411 patients will be enrolled from Asia at approximately 25 centers where Endeavor Resolute stent is commercially available. There are two study cohorts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Different patient subset | Experimental | Patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm. |
|
| 38 mm Cohort | Experimental | Patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting stent treatment | Device | Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort | TLF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. TVF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target vessel revascularization (TVR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death rate in the study. | 30d, 6m, 9m, 12m, 18m, 2yr, 3yr |
| MI | Myocardial infarction (MI) rate in the study. | 30d, 6m, 9m, 12m, 18m, 2yr, 3yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robaayah Zambahari, MBBS, MRCP, FRCP, FACC | National Heart Institute (IJN), Malaysia | Principal Investigator |
| Michael Kang-Yin Lee, MBBS | Queen Elizabeth Hospital, HK | Principal Investigator |
| Shirish Hiremath, MD | Ruby Hall Clinic, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Care Clinic | Ahmedabad | Gujarat | 380015 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953695 | Result | Lee M, Hiremath S, Zambahari R, Leon M, Mauri L, Yeung A; RESOLUTE US and RESOLUTE Asia Investigators. One-year outcomes of percutaneous coronary intervention with the 38-mm Resolute zotarolimus-eluting stent. Am J Cardiol. 2013 Nov 1;112(9):1335-41. doi: 10.1016/j.amjcard.2013.06.012. Epub 2013 Aug 14. |
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| Cardiac death and MI | Cardiac death and myocardial infarction (MI) rate in the study | 30d, 6m, 9m, 12m, 18m, 2yr, 3yr |
| MACE | MACE composite endpoint and each individual component (death, myocardial infarction (MI) (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods) | 30d, 6m, 9m, 12m, 18m, 2yr, 3yr |
| TLF | TLF composite endpoint and each individual component (cardiac death, target vessel MI or clinically-driven TLR) | For 38mm cohort it is 30d, 6m, 9m, 18m, 2yr and 3yr. For dual vessel cohort it is 30d, 6m, 9m, 12m, 18m, 2yr and 3yr |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001157 | Arterial Occlusive Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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