PROMUS Element Plus US Post-Approval Study

NCT ID: NCT01589978

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2681 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2018-06-30

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PROMUS Element

Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Group Type: EXPERIMENTAL

PROMUS Element Plus Coronary Stent System

Intervention Type: 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).

Aspirin

Intervention Type: 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.

P2Y12 antagonist

Intervention Type: 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)

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

PROMUS Element stent; Acetyl salicylic acid; PLAVIX (clopidogrel); TICLID (ticlopidine); EFFIENT (prasugrel); BRILINTA (ticagrelor)

Eligibility Criteria

Inclusion Criteria

• The population will include consecutive, consented patients.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter M Maurer, MPH

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Huntsville Hospital - The Heart Center, PC

Huntsville, Alabama, United States

Springhill Medical Center

Mobile, Alabama, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Mercy General Hospital

Sacramento, California, United States

Christiana Hospital

Newark, Delaware, United States

Brandon Regional Hospital

Brandon, Florida, United States

North Florida Regional Medical Center

Gainesville, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Bay Medical Center

Panama City, Florida, United States

Martin Memorial Health Systems - Martin Memorial Medical Center

Stuart, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Coliseum Medical Center

Macon, Georgia, United States

Redmond Regional Medical Center

Rome, Georgia, United States

Blessing Hospital

Quincy, Illinois, United States

IU Health North Medical Center

Carmel, Indiana, United States

Franciscan St. Francis Hospital

Indianapolis, Indiana, United States

Community Heart and Vascular Hospital

Indianapolis, Indiana, United States

St. Joseph Hospital

Lexington, Kentucky, United States

Cardiovascular Research, LLC

Shreveport, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Cape Cod Hospital

Hyannis, Massachusetts, United States

Lakeland Hospitals at St. Joseph

Saint Joseph, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

North Memorial Medical Center

Minneapolis, Minnesota, United States

United Hospital - St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Forest County General Hospital

Hattiesburg, Mississippi, United States

St. John's Regional Health Center (Springfield)

Springfield, Missouri, United States

Cox Medical Centers

Springfield, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

New York University Medical Center

New York, New York, United States

St. Elizabeth Medical Center

Utica, New York, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

St. Francis Hospital

Tulsa, Oklahoma, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

University Medical Center-Greenville Memorial Hospital

Greenville, South Carolina, United States

St. Francis Health System - St. Francis Hospital

Greenville, South Carolina, United States

Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States

South Austin Hospital

Austin, Texas, United States

VA North Texas Health Care System

Dallas, Texas, United States

Presbyterian Hospital of Dallas

Dallas, Texas, United States

University of Utah Hospital and Clinics

Salt Lake City, Utah, United States

Chippenham Medical Center

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Meriter Hospital

Madison, Wisconsin, United States

Marshfiled Clinic

Weston, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37354778 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33636137 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26732420 (View on PubMed)

Other Identifiers

S2066

Identifier Type: -

Identifier Source: org_study_id