PROMUS Element Plus US Post-Approval Study

NCT01589978 | Completed Phase 4 Results

• 1 other identifier: S2066
• Study Type: interventional
• Target: 2,681
• Locations: 1 country
• Sites: 52

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

drug-eluting stent; DES; atherosclerosis; everolimus

Outcome Measures

Primary Outcomes (1)

• Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients

  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%)

  12 months

Secondary Outcomes (20)

• Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients

  12 months

• Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients

  ≤24 hours, 30 days, 180 days, annually through 5 years

• Rate of Longitudinal Stent Deformation

  Index Procedure

• Major Adverse Cardiac Event Rate (MACE)

  ≤24 hours, 30 days, 180 days, annually through 5 years

• Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent

  ≤24 hours, 30 days, 180 days, annually through 5 years

Study Arms (1)

PROMUS Element

EXPERIMENTAL

Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Device: PROMUS Element Plus Coronary Stent System; Drug: Aspirin; Drug: P2Y12 antagonist

Interventions

PROMUS Element Plus Coronary Stent System DEVICE

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).

Also known as: PROMUS Element stent

PROMUS Element

Aspirin DRUG

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.

Also known as: Acetyl salicylic acid

PROMUS Element

P2Y12 antagonist DRUG

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)

Also known as: PLAVIX (clopidogrel), TICLID (ticlopidine), EFFIENT (prasugrel), BRILINTA (ticagrelor)

PROMUS Element

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The population will include consecutive, consented patients.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (52)

Huntsville Hospital - The Heart Center, PC

Huntsville, Alabama, 35801, United States

Location

Springhill Medical Center

Mobile, Alabama, 36608, United States

Location

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, 72401, United States

Location

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Brandon Regional Hospital

Brandon, Florida, 33511, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Bay Medical Center

Panama City, Florida, 32401, United States

Location

Martin Memorial Health Systems - Martin Memorial Medical Center

Stuart, Florida, 34996, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Coliseum Medical Center

Macon, Georgia, 31217, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Blessing Hospital

Quincy, Illinois, 62301, United States

Location

IU Health North Medical Center

Carmel, Indiana, 46032, United States

Location

Franciscan St. Francis Hospital

Indianapolis, Indiana, 46237, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

St. Joseph Hospital

Lexington, Kentucky, 40504, United States

Location

Cardiovascular Research, LLC

Shreveport, Louisiana, 71103, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Lakeland Hospitals at St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

North Memorial Medical Center

Minneapolis, Minnesota, 55422, United States

Location

United Hospital - St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Forest County General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

St. John's Regional Health Center (Springfield)

Springfield, Missouri, 65804, United States

Location

Cox Medical Centers

Springfield, Missouri, 65807, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York University Medical Center

New York, New York, 10011, United States

Location

St. Elizabeth Medical Center

Utica, New York, 13501, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University Medical Center-Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

St. Francis Health System - St. Francis Hospital

Greenville, South Carolina, 29607, United States

Location

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, 29572, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

South Austin Hospital

Austin, Texas, 78745, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Chippenham Medical Center

Richmond, Virginia, 23225, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Meriter Hospital

Madison, Wisconsin, 53713, United States

Location

Marshfiled Clinic

Weston, Wisconsin, 55476, United States

Location

Related Publications (3)

• Beerkens FJ, Cao D, Batchelor W, Sartori S, Kandzari DE, Davis S, Tamis L, Wang JC, Othman I, Vogel B, Spirito A, Subramaniam V, Gigliotti OS, Haghighat A, Feng Y, Singh S, Lopez M, Giugliano G, Horwitz PA, Dangas G, Mehran R. Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries). Am J Cardiol. 2023 Aug 1;200:204-211. doi: 10.1016/j.amjcard.2023.05.028. Epub 2023 Jun 22.

  PMID: 37354778 DERIVED

• Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.

  PMID: 33636137 DERIVED

• Kandzari DE, Amjadi N, Caputo C, Rowe SK, Williams J, Tamboli HP, Christen T, Allocco DJ, Dawkins KD. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]). Am J Cardiol. 2016 Feb 15;117(4):539-545. doi: 10.1016/j.amjcard.2015.11.043. Epub 2015 Dec 7.

  PMID: 26732420 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Aspirin; Purinergic P2Y Receptor Antagonists; Clopidogrel; Ticlopidine; Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Peter Maurer, Director Clinical Trials
• Organization: Boston Scientific

Peter.Maurer@bsci.com

508-683-6678

Study Officials

• Peter M Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: June 1, 2018
• Last Updated: July 26, 2018
• Results First Posted: May 3, 2016

Record last verified: 2018-06

Locations

US (52)