Status:
COMPLETED
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Patient must be at least 18 years of age
- Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
- For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
- Patient has a left ventricular ejection fraction (LVEF) \>=30% as measured within 30 days prior to enrollment
- Patient is willing to comply with all protocol-required follow-up evaluations
- Angiographic Inclusion Criteria (visual estimate):
- \- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter ≥2.25 mm and \<2.5 mm. Target lesion length must measure ≤28 mm by visual estimate. Target lesion must be located in a major coronary artery or branch with visually estimated stenosis ≥50% and \<100% with Thrombolysis In Myocardial Infarction (TIMI) flow \>1.
Exclusion
- Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (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 creatine kinase-myoglobin band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.
- If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \>2× ULN.
- 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.
- Troponin \>1× ULN with at least one of the following.
- Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]);
- Development of pathological Q waves in the ECG; or
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- 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.
- Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
- Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with protocol or confound data interpretation
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01498692
Start Date
February 1 2009
End Date
May 1 2015
Last Update
March 26 2019
Active Locations (23)
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1
Bakersfield Memorial Hospital
Bakersfield, California, United States, 93301
2
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, United States, 34471
3
Florida Hospital
Orlando, Florida, United States, 32803
4
St. John's Hospital
Springfield, Illinois, United States, 62701