The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ 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 The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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).
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.
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.
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.
Time frame: 12 months
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.
Time frame: 30 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Target Vessel Failure (TVF)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scripps Clinic
La Jolla, California, United States
Mercy General Hospital
Sacramento, California, United States
Alvarado Hospital
San Diego, California, United States
MediQuest Research Group Inc. at Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
Maine Medical Center
Portland, Maine, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
...and 20 more locations
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.
Time frame: 12 months
All Cause Death
Time frame: 30 Days
All Cause Death
Time frame: 6 months
All Cause Death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: >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)
Time frame: 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
Time frame: 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
Time frame: In hospital (average of 1-2 days post index procedure)