PROMUS Element Plus US Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01589978
First received: May 1, 2012
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.


Condition Intervention Phase
Coronary Artery Disease
Device: PROMUS Element Plus Coronary Stent System
Drug: Aspirin
Drug: P2Y12 antagonist
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)


Secondary Outcome Measures:
  • Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)

  • Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    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)

  • Rate of Longitudinal Stent Deformation [ Time Frame: Index Procedure ] [ Designated as safety issue: Yes ]
    Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent. Limited data suggest coronary artery calcification, vessel tortuosity, and stent malapposition may be associated with increased risk of longitudinal stent deformation.

  • Major Adverse Cardiac Event Rate (MACE) [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, myocardial infarction, and target vessel revascularization

  • Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent

  • Myocardial Infarction (MI) Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

  • Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

  • Cardiac Death Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

  • Rate of Cardiac Death Events Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

  • Target Vessel Revascularization (TVR) Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: No ]
    Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

  • Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: No ]
    Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

  • Cardiac Death or Myocardial Infarction (MI) Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    See individual descriptions of events.

  • Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    See individual descriptions of events.

  • Target Vessel Failure (TVF) Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]

    Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) 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 MI or death was related to the target vessel it will be considered TVF.


  • Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]

    Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) 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 MI or death was related to the target vessel it will be considered TVF.


  • All Death Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    All death includes cardiac death and non-cardiac death.

  • Non-cardiac Death Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]

    Non-cardiac death is defined as death not due to cardiac causes.

    Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.


  • All Death or Myocardial Infarction Rate [ Time Frame: ≤24 hours, 30 days, 180 days, annually through 5 years ] [ Designated as safety issue: Yes ]
    See description of individual events.

  • Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)


Estimated Enrollment: 2689
Study Start Date: May 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROMUS Element
Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Device: PROMUS Element Plus Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
Other Name: PROMUS Element stent
Drug: Aspirin
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
Other Name: Acetyl salicylic acid
Drug: P2Y12 antagonist

Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.

  • Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily)
  • Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling)
  • Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided.
  • Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)
Other Names:
  • PLAVIX (clopidogrel)
  • TICLID (ticlopidine)
  • EFFIENT (prasugrel)
  • BRILINTA (ticagrelor)

Detailed Description:

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The population will include consecutive, consented patients.

Exclusion Criteria:

  • There are no exclusion criteria in this all-comers study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589978

  Show 51 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Peter M Maurer, MPH Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01589978     History of Changes
Other Study ID Numbers: S2066
Study First Received: May 1, 2012
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
drug-eluting stent
DES
atherosclerosis
everolimus

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Aspirin
Clopidogrel
Everolimus
Sirolimus
Ticagrelor
Analgesics
Analgesics, Non-Narcotic
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents

ClinicalTrials.gov processed this record on October 30, 2014