The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions (PLATINUM LL)

NCT01500434 | Completed Phase 3 Results DMC

• 1 other identifier: S2046C
• Study Type: interventional
• Target: 102
• Locations: 7 countries
• Sites: 30

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 coronary artery lesions. The lesions can be longer than average-sized.

Conditions

Coronary Artery Disease

Keywords

drug-eluting stents; DES; atherosclerotic

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (25)

• Target Lesion Failure (TLF)

  30 Days

• Target Lesion Failure (TLF)

  6 Months

• Target Vessel Failure (TVF)

  30 Days

• Target Vessel Failure (TVF)

  6 months

• Target Vessel Failure (TVF)

  12 months

Study Arms (1)

PROMUS Element

EXPERIMENTAL

Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent

Device: PROMUS Element Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine

Interventions

PROMUS Element Coronary Stent System DEVICE

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).

PROMUS Element

Aspirin DRUG

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.

PROMUS Element

Thienopyridine DRUG

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.

Also known as: A brand name for clopidogrel is PLAVIX., A brand name for ticlopidine is TICLID.

PROMUS Element

Eligibility Criteria

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

You may qualify if:

• 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
• \- Target lesion must be a de novo lesion \>24 mm and ≤34 mm in length (by visual estimate) in a native coronary artery ≥2.50 mm to ≤4.25 mm in diameter (by visual estimate). Target lesion must be in a major coronary artery or branch with visually estimated stenosis \>=50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.

You may not qualify if:

• Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute 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 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (30)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Alvarado Hospital

San Diego, California, 92120, United States

Location

MediQuest Research Group Inc. at Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Health Research and Innovation Institute

Columbus, Ohio, 43214, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

TexSAn Heart Hospital

San Antonio, Texas, 78229, United States

Location

Providence Health & Services - Washington

Spokane, Washington, 99204, United States

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincents Public,

Fitzroy, Victoria, 3065, Australia

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

UZ Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Location

P. Stradins University Hospital

Riga, LV-1002, Latvia

Location

North Shore Hospital

Takapuna, 0622, New Zealand

Location

Related Publications (2)

• Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

  PMID: 29217001 DERIVED

• Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

  PMID: 24905795 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; thienopyridine

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

Results Point of Contact

• Title: Ruth Starzyk, PhD
• Organization: Boston Scientific

ruth.starzyk@bsci.com

508-683-6577

Study Officials

• Peter M. Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2015
• Last Updated: March 26, 2019
• Results First Posted: February 14, 2012

Record last verified: 2019-03

Locations

LA (1); NZ (1); US (21); BE (2); AU (2); FR (1); JP (2)