A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)

NCT00824434 | Completed Phase 3 Results DMC

• 1 other identifier: S2051
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 17

Brief Summary

Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

Atherosclerosis; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Cardiac Events (Composite)

  Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components.

  30 days

Secondary Outcomes (15)

• In-stent Late Loss

  9 months

• Occurance of Post-procedure Incomplete Stent Apposition

  Post-procedure

• Myocardial Infarction (MI)

  12 months

• All-cause Mortality

  12 months

• Target Lesion Revascularization (TLR)

  30 Days

Study Arms (1)

Experimental Stent

EXPERIMENTAL

Device: PROMUS Element™

Interventions

PROMUS Element™ DEVICE

Drug eluting coronary stent system

Experimental Stent

Eligibility Criteria

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

You may qualify if:

• Patient (or legal guardian) understands the study requirements and the treatment procedures and provides 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 (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
• 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 specified follow-up evaluations
• Target lesion must be a de novo lesion located in a native coronary artery with visually estimated diameter of \>=2.25 mm and \<=4.25 mm
• Target lesion length must measure (by visual estimate) \<=34 mm
• 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 myocardial infarction (MI)
• Patient has had a known diagnosis of recent MI (within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
• Patients are excluded if any of the following criteria are met at the time of the index procedure
• If creatine kinase, MB band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of the creatine kinase (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, the patients are excluded if the following criterion is met at the time of the index procedure.
• Troponin \>1× ULN with at least one of the following.
• Patient has ischemic symptoms and electrocardiogram (ECG) changes indicative of ongoing ischemia (e.g., \>1mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]);
• Development of pathological Q-waves in the ECG
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
• Note: For 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 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 the 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 (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (17)

St. Vincent's Hospital - Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincent Hospital (Melbourne)

Fitzroy, Victoria, 3065, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

The Prince Charles Hospital

Brisbane, 4032, Australia

Location

Liverpool Hospital

Liverpool, 2170, Australia

Location

Sir Charles Gairdner Hospital

Perth, 6009, Australia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Middlemore Hospital

Otahuhu, Auckland, New Zealand

Location

North Shore Hospital

Takapuna, Auckland, 0622, New Zealand

Location

Christchurch Hospital

Christchurch, 8001, New Zealand

Location

Dunedin Hospital

Dunedin, 9001, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

National University Hospital, Singapore

Singapore, Singapore, 119074, Singapore

Location

National Heart Centre Singapore

Singapore, Singapore, 168752, Singapore

Location

Related Publications (1)

• Meredith IT, Whitbourn R, Scott D, El-Jack S, Zambahari R, Stone GW, Teirstein PS, Starzyk RM, Allocco DJ, Dawkins KD. PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses. EuroIntervention. 2011 May;7(1):84-90. doi: 10.4244/EIJV7I1A15.

  PMID: 21550907 RESULT

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ruth.starzyk@bsci.com

508-683-6577

Study Officials

• Ian T. Meredith, MBBS

  Monash Medical Centre

  PRINCIPAL INVESTIGATOR

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: January 15, 2009
• First Posted: January 16, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: August 1, 2010
• Last Updated: August 30, 2012
• Results First Posted: March 7, 2012

Record last verified: 2012-08

Locations

MY (1); AU (9); NZ (5); SG (2)