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The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Stent | Experimental | Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDT-4107 Zotarolimus-Eluting Coronary Stent | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure(TLF) | Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR) | 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Cardiac Event) | Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods. | Baseline and 9 month |
| Late Lumen Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Sohana Kamakura General Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shonan Kamakura General Hospital | Kanagawa | 247-8533 | Japan |
| 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. |
| Label | URL |
|---|---|
| Medtronic Clinical Trials Link | View source |
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There was no significant episode for screening processes.
In this study the first patient was enrolled in June 2011 and the last patient was enrolled in January 2012 in eleven hospitals in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stent Placement | Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.
| Baseline and 9 months |
| Binary Angiographic Restenosis | Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used. | Baseline and 9 month |
| Minimum Luminal Diameter | The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory. | 9 month |
| Percent Diameter Stenosis | The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA). | Baseline and 9 month |
| Clinical Endpoints | Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis | 5 Years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stent Placement | Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Target Lesion Failure(TLF) | Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR) | All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population. | Posted | Number | percentage of TLF | 9 month |
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| Secondary | MACE (Major Adverse Cardiac Event) | Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods. | 65 patients were analyzed as ITT population | Posted | Number | percentage of patient | Baseline and 9 month |
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| Secondary | Late Lumen Loss | Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month. | 67 Lesions in 65 patients are analysed. | Posted | Mean | Standard Deviation | mm | Baseline and 9 months |
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| Secondary | Binary Angiographic Restenosis | Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used. | 67 lesions in 65 patients were analysed. | Posted | Number | percentage of patient | Baseline and 9 month |
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| Secondary | Minimum Luminal Diameter | The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory. | 67 lesions in 65 patient were analyzed. | Posted | Mean | Standard Deviation | mm | 9 month |
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| Secondary | Percent Diameter Stenosis | The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA). | 67 lesions in 65 patients were analyzed. | Posted | Mean | Standard Deviation | % DS (diameter stenosis) | Baseline and 9 month |
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| Secondary | Clinical Endpoints | Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis | Not Posted | 5 Years | Participants |
Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected.
Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
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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 | Stent Placement | Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent | 16 | 65 | 25 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| CATARCT | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| GASTRIC ULCER HAEMORRAGE | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| MALTI-ORGAN FAILURE | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| ROAD TRAFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| LUMBER SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| ACTIVITY OF DIALY LIVING IMPAIRED | Social circumstances | MedDRA (10.0) | Non-systematic Assessment |
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| ATERIOSCLEROSIS OBLITERANS | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| BLOOD TRIGYCERIES INCREASED | Investigations | MedDRA (10.0) | Non-systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hiroko Ookubo | Study Manager | +81-3-6430-7017 | hiroko.ookubo@medtronic.com |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
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