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A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROMUS Element | Experimental | everolimus-eluting coronary stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMUS Element | Device | PROMUS Element Everolimus-Eluting Coronary Stent System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event) | A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarction (MI) (Percentage of Participants With an Event) | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN |
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Inclusion Criteria:
Exclusion Criteria:
Patient has clinical symptoms and/or ECG changes consistent with acute myocardial infarction (MI)
Patient has had a known diagnosis of recent MI (i.e., within 72 hours prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling the patient.
Patient has received an organ transplant or is on a waiting list for an organ transplant
Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Patient is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) for indications other than acute coronary syndrome
Patient has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3
Patient has a white blood cell (WBC) count <3,000 cells/mm^3
Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
Patient is on dialysis or has known renal insufficiency (i.e., Creatinine > 2.0 mg/dl or >150 μmol/L)
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure (excluding PCI of the non-target lesion within the target vessel treated during the index procedure (Refer to Multiple Interventions During Index Procedure))
Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
Planned PCI or CABG after the index procedure
Patient previously treated at any time with coronary intravascular brachytherapy
Patient has a known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
Patient has one of the following.
Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Patient with known intention to procreate within 12 months after the index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
Patient has more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Shonan Kamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | Japan | |||
| Hoshi General Hospital |
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Enrollment of 60 patients was planned and 60 patients were enrolled at 14 sites in Japan from February 8, 2010 to June 15, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | PROMUS Element | Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PROMUS Element | Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device) |
| 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 | Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event) | A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
9 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 | PROMUS Element | Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | MedDra 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDra 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Starzyk, Ph.D. | Boston Scientific Corporation | 508-683-6577 | ruth.starzyk@bsci.com |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 9 months |
| All-cause Death (Percentage of Participants With an Event) | Participants who died from any cause | 9 months |
| Cardiac Death (Percentage of Participants With an Event) | Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death. | 9 months |
| Target Vessel Revascularization (Percentage of Participants With an Event) | Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR. | 9 months |
| Target Lesion Revascularization (Percentage of Participants With an Event) | Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR. | 9 months |
| Target Vessel Failure (TVF) (Percentage of Participants With an Event) | Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event. | 9 months |
| Target Lesion Failure (TLF) (Percentage of Participants With an Event) | Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event. | 9 months |
| Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) | 0-30 Days (Early) |
| Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) | >30 days - 9 months |
| Technical Success (Percentage of Stents) | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent | At time of index procedure |
| Clinical Procedural Success (Percentage of Participants) | Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death. | While participant is in the hospital |
| Koriyama-shi |
| Fukushima |
| Japan |
| Hakodate Municipal Hospital | Hakodate-shi | Hokkaido | Japan |
| Hokkaido Social Insurance Hospital | Sapporo | Hokkaido | Japan |
| Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa | Japan |
| Japan Labour Health and Welfare Organization Kanto Rosai Hospital | Kawasaki-shi | Kanagawa | Japan |
| Saiseikai Yokohama-City Eastern Hospital | Yokohama | Kanagawa | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | Japan |
| Japan Labour Health and Welfare Organization Kumamoto Rosai Hospital | Yatsushiro-shi | Kumamoto | Japan |
| Kyoto-Katsura Hospital | Kyoto | Kyoto | Japan |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken | Japan |
| Jichi Medical University Hospital | Shimotsuke-shi | Tochigi | Japan |
| The Cardiovascular Institute Hospital | Minatoku | Tokyo-to | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo-to | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo-tu | Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comorbidities | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. Not all participants have one of these comorbidity measures. | Number | participant |
|
| Cardiac History | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | participants |
|
| Cardiac History: Left Ventricular Ejection Fraction | Left ventricular ejection fraction (LVEF) is an assessment of the amount of blood emptied from the left ventricle during systolic contraction, which is indicative of global ventricular function. | Mean | Standard Deviation | percent |
|
| Cardiac Risk Factors | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. | Number | participants |
|
| Lesion Characteristic: Target Lesion Vessel | Number | Lesions |
|
| Lesion Characteristic: Lesion Location | Number | lesions |
|
| Lesion Characteristics | Mean | Standard Deviation | millimeter |
|
| Lesion Characteristic: Percent Diameter Stenosis | Extent of stenosis of the target lesion (measured as percent of area stenosed) | Mean | Standard Deviation | percent stenosis |
|
| Lesion Characteristics | The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group. Not all participants have one of these lesion characteristics. | Number | participants |
|
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class | Type A:minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, absence of thrombus. Type B:moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, presence of thrombus; type B1 has one adverse characteristic and B2 has ≥2. Type C:severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions. | Number | lesions |
|
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow | TIMI 0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion | Number | lesions |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Myocardial Infarction (MI) (Percentage of Participants With an Event) | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | All-cause Death (Percentage of Participants With an Event) | Participants who died from any cause | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Cardiac Death (Percentage of Participants With an Event) | Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Target Vessel Revascularization (Percentage of Participants With an Event) | Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Target Lesion Revascularization (Percentage of Participants With an Event) | Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR. | Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Target Vessel Failure (TVF) (Percentage of Participants With an Event) | Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Target Lesion Failure (TLF) (Percentage of Participants With an Event) | Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 9 months |
|
|
|
| Secondary | Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 0-30 Days (Early) |
|
|
|
| Secondary | Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | >30 days - 9 months |
|
|
|
| Secondary | Technical Success (Percentage of Stents) | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent | Analysis was intention to treat | Posted | Number | percentage of stents | At time of index procedure | Stents Implanted | Participants |
|
|
|
| Secondary | Clinical Procedural Success (Percentage of Participants) | Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death. | Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | While participant is in the hospital |
|
|
|
| 11 |
| 60 |
| 7 |
| 60 |
| Cardiac failure congestive | Cardiac disorders | MedDra 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDra 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 12.0 | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDra 12.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDra 12.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDra 12.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDra 12.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDra 12.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDra 12.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDra 12.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra 12.0 | Systematic Assessment |
|
| Thalamus haemorrhage | Nervous system disorders | MedDra 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra 12.0 | Systematic Assessment |
|
In Japan, the study agreement was executed between the head of hospital (not PI) and Boston Scientific Japan. The site must get written approval before they publish any study data/information to an outside community such as a scientific society.
| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |