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The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Integrity | Other | Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Integrity Stent | Device | Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI | 12 months | |
| Clinical Endpoint: Death | 12 months |
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General and Angiographic Inclusion Criteria highlights:
General and Angiographic Exclusion Criteria highlights:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Caputo, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
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230 PEG subjects were enrolled from 29 study sites in the United States. The first subject was enrolled on July 23, 2012 and the last subject was enrolled on May 31, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Enrollment Group (PEG) | Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Enrollment Group (PEG) | Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) | The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study. | Posted | Number | 95% Confidence Interval | 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 | Primary Enrollment Group (PEG) | Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Bousquette, Clinical Research Director | Medtronic, Coronary Clinical Affairs | (707) 591-2967 | lisa.r.bousquette@medtronic.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Dual Antiplatelet Therapy (DAPT) Compliance | 12 months |
| Clinical Endpoint: TLR | 12 months |
| Clinical Endpoint: TVR | 12 months |
| Clinical Endpoint: MI | 12 months |
| Clinical Endpoint: ST | 12 months |
| Clinical Endpoint: Stroke | 12 months |
| Clinical Endpoint: Bleeding Complications in General | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI | Posted | Number | percentage of composite | 12 months |
|
|
|
| Secondary | Clinical Endpoint: Death | Posted | Number | percentage of death | 12 months |
|
|
|
| Secondary | Dual Antiplatelet Therapy (DAPT) Compliance | Posted | Number | percentage of compliance | 12 months |
|
|
|
| Secondary | Clinical Endpoint: TLR | Posted | Number | percentage of TLR | 12 months |
|
|
|
| Secondary | Clinical Endpoint: TVR | Posted | Number | percentage of TVR | 12 months |
|
|
|
| Secondary | Clinical Endpoint: MI | Posted | Number | percentage of MIs | 12 months |
|
|
|
| Secondary | Clinical Endpoint: ST | Posted | Number | percentage of ST | 12 months |
|
|
|
| Secondary | Clinical Endpoint: Stroke | Posted | Number | percentage of strokes | 12 months |
|
|
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| Secondary | Clinical Endpoint: Bleeding Complications in General | Posted | Number | percentage of bleeding complications | 12 months |
|
|
|
| 88 |
| 230 |
| 51 |
| 230 |
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | Systematic Assessment |
|
| Arteriospasm Coronary | Cardiac disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
|
| Coronary Artery Dissection | Cardiac disorders | Systematic Assessment |
|
| In-Stent Coronary Artery Restenosis | Cardiac disorders | Systematic Assessment |
|
| Ischaemic Cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Deformity Of Orbit | Eye disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Mucosal Disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | Systematic Assessment |
|
| Mesenteric Artery Stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Drowning | General disorders | Systematic Assessment |
|
| Implant Site Haematoma | General disorders | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
|
| Oedema Peripheral | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Clostridium Difficile Colitis | Infections and infestations | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Urosepsis | Infections and infestations | Systematic Assessment |
|
| In-Stent Arterial Restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thrombosis In Device | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac Enzymes Increased | Investigations | Systematic Assessment |
|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | Systematic Assessment |
|
| Factitious Disorder | Psychiatric disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Therapeutic Embolisation | Surgical and medical procedures | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | Systematic Assessment |
|
| Arterial Haemorrhage | Vascular disorders | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | Systematic Assessment |
|
| Artery Dissection | Vascular disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Femoral Artery Occlusion | Vascular disorders | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | Systematic Assessment |
|
| Shock Haemorrhagic | Vascular disorders | Systematic Assessment |
|
| Vascular Occlusion | Vascular disorders | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Vascular disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Cardiac Enzymes Increased | Investigations | Systematic Assessment |
|
For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or any materials will be provided by Consultant to Sponsor for its approval at least sixty (60days) for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |