Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, multi-center, non-randomized, single-arm, open-label study 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 (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Integrity | Other | Resolute Integrity Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Integrity Stent | Device | Drug eluting stent (DES) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) | The combined clinical outcome of (all cause) mortality, MI or any revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint: Major Adverse Cardiac Events (MACE) | Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | 30 days, 6 months, 12 months |
| Composite Endpoint: Target Lesion Failure (TLF) |
Not provided
General and Angiographic Inclusion Criteria highlights:
General and Angiographic Exclusion Criteria highlights:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
Not provided
56 XL subjects were enrolled from 9 study sites in the United States. The first subject was enrolled on July 26, 2013 and the last subject was enrolled on October 27, 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Resolute Integrity US Extended Length Sub-Study (RI-US XL) | Resolute Integrity Stent Resolute Integrity Stent: Drug eluting stent (DES) Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Resolute Integrity US Extended Length Sub-Study (RI-US XL) | Resolute Integrity Stent Resolute Integrity Stent: Drug eluting stent (DES) Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure. |
| 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 combined clinical outcome of (all cause) mortality, MI or any revascularization | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 12 months |
|
1 Year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resolute Integrity US Extended Length Sub-Study (RI-US XL) | Resolute Integrity Stent Resolute Integrity Stent: Drug eluting stent (DES) Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute MI | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Bousquette, Clinical Research Director | Medtronic, Coronary & Structural Heart Clinical | 707-591-2967 | rs.medtroniccardiovascularclinicaltrials@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 30 days, 6 months, 12 months |
| Composite Endpoint: Target Vessel Failure (TVF), | The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 30 days, 6 months, 12 months |
| Composite Endpoint: Cardiac Death and Target Vessel MI | Combined rate of cardiac death and target vessel MI post-procedure | 30 days, 6 months, 12 months |
| Composite Endpoint: Target Vessel MI | Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel. | 30 days, 6 months, 12 months |
| Clinical Endpoint: Death | All deaths including cardiac death, vasular death and non-cardiovascular death | 30 days, 6 months, 12 months |
| Clinical Endpoint: Myocardial Infarction (MI) | All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions. | 30 days, 6 months, 12 months |
| Clinical Endpoint: Target Lesion Revascularization (TLR) | Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion. | 30 days, 6 months, 12 months |
| Clinical Endpoint: Target Vessel Revascularization (TVR) | Repeat PCI or CABG of the target vessel. | 30 days, 6 months, 12 months |
| Clinical Endpoint: Stent Thrombosis | All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions | Early Thrombosis (<=30 days), Late Thrombosis (31-360 days) |
| Clinical Endpoint: Stroke | Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours. | 30 days, 6 months, 12 months |
| Clinical Endpoint: Bleeding Complications in General | Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe. | 30 days, 6 months, 12 months |
| Dual Antiplatelet Therapy (DAPT) Compliance | Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days. | 30 days, 6 months, 12 months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Composite Endpoint: Major Adverse Cardiac Events (MACE) | Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Composite Endpoint: Target Lesion Failure (TLF) | 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 | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Composite Endpoint: Target Vessel Failure (TVF), | The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Composite Endpoint: Cardiac Death and Target Vessel MI | Combined rate of cardiac death and target vessel MI post-procedure | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Composite Endpoint: Target Vessel MI | Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Death | All deaths including cardiac death, vasular death and non-cardiovascular death | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Myocardial Infarction (MI) | All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Target Lesion Revascularization (TLR) | Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Target Vessel Revascularization (TVR) | Repeat PCI or CABG of the target vessel. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Stent Thrombosis | All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | Early Thrombosis (<=30 days), Late Thrombosis (31-360 days) |
|
|
|
| Secondary | Clinical Endpoint: Stroke | Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Clinical Endpoint: Bleeding Complications in General | Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe. | 2 subjects did not complete the 12 month follow up | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | Dual Antiplatelet Therapy (DAPT) Compliance | Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days. | At the time of the 12 month follow up there were 52 subjects with evaluable data | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| 1 |
| 56 |
| 45 |
| 56 |
| 45 |
| 56 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial Fibrilation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Coronary Artery Dissection | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal Detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Polyp Colerectal | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ischaemic Hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac Enzymes Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|
|
| 360 Days |
|
|