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| Name | Class |
|---|---|
| Medtronic Japan Co., Ltd. | INDUSTRY |
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The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Stent | Experimental | All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDT-4107 Drug Eluting Stent | Device | Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Lumen Loss (LLL) | The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD | Post procedure, 8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) | Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Shonan Kamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyohashi Heart Center | Aichi | 441-8530 | Japan | |||
| Hospital Hakodate Hokkaido |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25428602 | Derived | Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27. | |
| 24510638 |
| Label | URL |
|---|---|
| Medtronic Clinical Trials Link | View source |
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The first patient and the last patient were enrolled on Mar. 23, 2009 and Oct. 30, 2009 respectively. Total 100 patients were enrolled in this study from 14 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zotalolimus Eluting Sttent | All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis |
| 12 months |
| Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) | 8 months |
| Hokkaido |
| 041-8680 |
| Japan |
| Kansai Rosai Hospital | Hyōgo | 660-8511 | Japan |
| Kanto Rosai Hospital | Kanagawa | 211-8510 | Japan |
| Yokohama Tobu Hospital | Kanagawa | 230-0012 | Japan |
| Shonan Kamakura General Hospital | Kanagawa | 247-8533 | Japan |
| Kumamoto Rosai Hospital | Kumamoto | 866-8533 | Japan |
| Kyoto Katsura Hospital | Kyoto | 615-8256 | Japan |
| Kurashiki Central Hospital | Okayama | 710-8602 | Japan |
| Jichi Medical University Hospital | Tochigi | 329-0498 | Japan |
| The Cardiovascular Institute Hospital | Tokyo | 106-0032 | Japan |
| Showa University Hospita | Tokyo | 142-8666 | Japan |
| Toho University Medical Center, Ohashi Hospital | Tokyo | 153-6181 | Japan |
| Teikyo University Hospital | Tokyo | 173-8606 | Japan |
| Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7. |
| 23523454 | Derived | Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20. |
| 23468513 | Derived | Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zotalolimus Eluting Sttent | All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study. |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | In-stent Late Lumen Loss (LLL) | The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD | Actually a patient was excluded from this analysis because of death before 30 days follow up. | Posted | Mean | Standard Deviation | mm | Post procedure, 8 Months |
|
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| |||||||||||||||||||||||||
| Secondary | Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) | Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. | ITT population | Posted | Number | percentage of participants with TLF | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis | Not Posted | 12 months | |||||||||||||||||||||||||||||||||
| Secondary | Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) | Not Posted | 8 months |
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 | Zotalolimus Eluting Sttent | All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study. | 35 | 100 | 58 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| IN-STENT CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| MIOCARDIAL INFARCTION | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| COLONIC POLYP | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| LOWER GASTROINTESTINAL HEAMORRAGE | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| RECTOSIGMOID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| DECREASED ACTIVITY | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| PERCUTANEOUS CORONARY INTERVENTION | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CORONARY ARTERY RESTENOSIS | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| STOMATISIS | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| CHEST DISCONFORT | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| ASPARATATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| BLOOD CREATINE PHOPHOKINASE INCREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| BLOOD CREATINE PHOSPHOKINASE MB INCREASED | Investigations | MedDRA (14.0) | Systematic Assessment |
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| BLOOD PRESSURE DECREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| BLOOD UREA INCREASED | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hiroko Okubo | Medtronic Japan Co.,Ltd | +81-3-6430-7017 | rs.medtroniccardiovascularclinicaltrials@medtronic.com |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| Title | Denominators | Categories |
|---|
|