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
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Elementâ„¢ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.
The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).
During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.
This PLATINUM Long Lesion study is a sub-trial associated with the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROMUS Element | Experimental | Patients who received the PROMUSâ„¢ Element Everolimus-Eluting Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMUS Element Coronary Stent System | Device | PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 30 Days |
| Target Lesion Failure (TLF) |
Not provided
Inclusion Criteria:
Angiographic Inclusion Criteria (visual estimate):
- Target lesion must be a de novo lesion >24 mm and ≤34 mm in length (by visual estimate) in a native coronary artery ≥2.50 mm to ≤4.25 mm in diameter (by visual estimate). Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
Exclusion Criteria:
Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
Patients are excluded if any of the following criteria are met at time of the index procedure.
If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.
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/randomizing 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 index procedure
Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Patient has white blood cell (WBC) count <3,000 cells/mm3
Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])
Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure
Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure
Planned or actual target vessel(s) 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 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 (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
Patient has 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 index procedure
Patient with known intention to procreate within 12 months after 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 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure
Angiographic Exclusion Criteria (visual estimate):
Target lesion meets any of the following criteria:
Non-target lesion to be treated during the index procedure meets any of the following criteria:
Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter M. Maurer, MPH | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Mercy General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29217001 | Derived | Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070. | |
| 24905795 |
Not provided
Not provided
The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment of 102 patients was planned and 102 patients were enrolled at 30 sites in Australia, Belgium, France, Japan, Latvia, New Zealand, and the United States from February 10, 2009 to March 4, 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PROMUS Element | Patients who received the PROMUSâ„¢ Element Everolimus-Eluting Coronary Stent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Aspirin | Drug | Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter. |
|
| Thienopyridine | Drug | Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant. |
|
|
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| 6 Months |
| Target Vessel Failure (TVF) | TVF is defined as 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. | 30 Days |
| Target Vessel Failure (TVF) | TVF is defined as 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. | 6 months |
| Target Vessel Failure (TVF) | TVF is defined as 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. | 12 months |
| All Cause Death | 30 Days |
| All Cause Death | 6 months |
| All Cause Death | 12 months |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 30 Days |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 6 months |
| Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 12 months |
| Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 30 Days |
| Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 6 months |
| Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 12 months |
| Target Lesion Revascularization (TLR) | 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. | 30 days |
| Target Lesion Revascularization (TLR) | 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. | 6 months |
| Target Lesion Revascularization (TLR) | 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. | 12 months |
| Target Vessel Revascularization (TVR) | 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. | 30 days |
| Target Vessel Revascularization (TVR) | 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. | 6 months |
| Target Vessel Revascularization (TVR) | 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. | 12 months |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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) | 24 hours |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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) | >24 hours-30 days |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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) | 31-365 days |
| Acute Technical Success | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent | Index Procedure |
| Clinical Procedural Success | Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death | In hospital (average of 1-2 days post index procedure) |
| Sacramento |
| California |
| 95819 |
| United States |
| Alvarado Hospital | San Diego | California | 92120 | United States |
| MediQuest Research Group Inc. at Munroe Regional Medical Center | Ocala | Florida | 34471 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27610 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio Health Research and Innovation Institute | Columbus | Ohio | 43214 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma | 73120 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| TexSAn Heart Hospital | San Antonio | Texas | 78229 | United States |
| Providence Health & Services - Washington | Spokane | Washington | 99204 | United States |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St. Vincents Public, | Fitzroy | Victoria | 3065 | Australia |
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| UZ Gasthuisberg | Leuven | B-3000 | Belgium |
| Clinique Pasteur | Toulouse | 31076 | France |
| Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa | Japan |
| Sakurabashi Watanabe Hospital | Osaka | Osaka | Japan |
| P. Stradins University Hospital | Riga | LV-1002 | Latvia |
| North Shore Hospital | Takapuna | 0622 | New Zealand |
| Derived |
| Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PROMUS Element | Patients who received the PROMUSâ„¢ Element Everolimus-Eluting Coronary Stent |
| 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 |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participant |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| 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: Ejection Fraction | 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 |
| ||||||||||||||||||||||
| 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. | Number | Participants |
| ||||||||||||||||||||||
| Lesion Characteristic: Target Lesion Vessel | Number | Lesions |
| |||||||||||||||||||||||
| Lesion Characteristic: Lesion Location | Number | Lesions |
| |||||||||||||||||||||||
| Lesion Characteristics | Mean | Standard Deviation | millimeters |
| ||||||||||||||||||||||
| Lesion Characteristic: Percent Diameter Stenosis | Mean | Standard Deviation | percent |
| ||||||||||||||||||||||
| Lesion Characteristics | Number | Lesions |
| |||||||||||||||||||||||
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class | Type A lesions: 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, and an absence of thrombus. Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus. Type C lesions: 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 |
|
| 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) | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set. | Posted | Number | percentage of participants | 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint. | Posted | Number | percentage of participants | 30 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Lesion Failure (TLF) | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. | 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 | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Failure (TVF) | TVF is defined as 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. | 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Failure (TVF) | TVF is defined as 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. | 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 | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Failure (TVF) | TVF is defined as 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. | 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 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Cause 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 | 30 Days |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Cause 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 | 6 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Cause 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 | 12 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 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 | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiac Death Related to the Target Vessel | Cardiac death is defined as Death due to any of the following: acute MI; 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 | 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 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 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 | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Myocardial Infarction (MI) Related to the Target Vessel | New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing 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×normal | 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 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Lesion Revascularization (TLR) | 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. | 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Lesion Revascularization (TLR) | 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. | 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 | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Lesion Revascularization (TLR) | 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. | 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 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Revascularization (TVR) | 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. | 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Revascularization (TVR) | 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. | 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 | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Vessel Revascularization (TVR) | 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. | 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 | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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 | 24 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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 | >24 hours-30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 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 | 31-365 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Technical Success | 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 | Index Procedure | stents | stents |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Procedural Success | Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death | Analysis was intention to treat | Posted | Number | percentage of participants | In hospital (average of 1-2 days post index procedure) |
|
|
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 | PROMUS Element | Patients who received the PROMUSâ„¢ Element Everolimus-Eluting Coronary Stent | 34 | 102 | 33 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth Starzyk, PhD | Boston Scientific | 508-683-6577 | ruth.starzyk@bsci.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| C446540 | thienopyridine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Asian |
|
| Black of African Heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| Belgium |
|
| Australia |
|
| Latvia |
|
| Japan |
|
| New Zealand |
|
| Previous Myocardial Infarction (MI) |
|
| Congestive Heart Failure |
|
| Stable Angina |
|
| Unstable Angina |
|
| Silent Ischemia |
|
| Hyperlipidemia Requiring Medication |
|
| Hypertension Requiring Medication |
|
| Family History of Coronary Artery Disease |
|
| History of Cerebrovascular Accident |
|
| History of Renal Disease |
|
| History of Gastrointestinal Bleeding |
|
| Right Coronary Artery |
|
| Mid |
|
| Distal |
|
| Lesion Length |
|
| > 90 Degree Bend |
|
| Tortuosity, any |
|
| Calcification, any |
|
| Total Occlusion |
|
| Bifurcation |
|
| Title | Measurements |
|---|---|
|
| Type B2 |
|
| Type C |
|
| TIMI 2 |
|
| TIMI 3 |
|
|
|
|
|
|
| Categories |
|---|
|
| Categories |
|---|
|
| Categories |
|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|