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Trial record 28 of 78 for:    "Heart Disease" | "Cobalt"

A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00828087
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Sabate, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE January 23, 2009
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. [ Time Frame: First year ]
Change History Complete list of historical versions of study NCT00828087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • All cause and cardiac mortality [ Time Frame: at 1 year and yearly up to 5 years ]
  • Recurrent myocardial infarction [ Time Frame: at 1 year and yearly up to 5 years ]
  • Target lesion revascularization [ Time Frame: at 1 year and yearly up to 5 years ]
  • Target vessel revascularization [ Time Frame: at 1 year and yearly up to 5 years ]
  • Stent thrombosis [ Time Frame: at 1 year and yearly up to 5 years ]
  • Clinical device success [ Time Frame: Procedure moment ]
    Successful delivery and deployment of the first inserted stent and a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment.
  • Clinical procedure success [ Time Frame: procedure moment ]
    Successful delivery and deployment of study stent in the target lesion and successful removal of the stent delivery system with a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment without the occurrence of serious cardiac events important for ischemia during hospitalization, with a maximum of seven days after the initial procedure.
  • Major and minor bleeding [ Time Frame: at 1 year and yearly up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
  • All cause and cardiac mortality [ Time Frame: at 1 year and yearly up to 5 years ]
  • Recurrent myocardial infarction [ Time Frame: at 1 year and yearly up to 5 years ]
  • Target lesion revascularization [ Time Frame: at 1 year and yearly up to 5 years ]
  • Target vessel revascularization [ Time Frame: at 1 year and yearly up to 5 years ]
  • Stent thrombosis [ Time Frame: at 1 year and yearly up to 5 years ]
  • Clinical device success [ Time Frame: Procedure moment ]
  • Clinical procedure success [ Time Frame: procedure moment ]
  • Major and minor bleeding [ Time Frame: at 1 year and yearly up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study
Official Title  ICMJE A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study
Brief Summary

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

Detailed Description

Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI).

Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,

Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.

The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

The primary endpoint is the combined endpoint of Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year (patient oriented endpoint suggested by the ARC definitions).

The following secondary endpoints will be examined:

  • All cause and cardiac mortality at 1 year and yearly up to 5 years.
  • Recurrent myocardial infarction at 1 year and yearly up to 5 years.
  • Target lesion revascularization at 1 year and yearly up to 5 years.
  • Target vessel revascularization at 1 year and yearly up to 5 years.
  • Stent thrombosis (according to the new definitions proposed by the Academic Research Consortium) at 1 year and yearly up to 5 years.
  • Clinical device success
  • Clinical procedure success.
  • Major and minor bleeding at 1 year and yearly up to 5 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Everolimus Eluting Coronary Stent System
    Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
    Other Name: N/H
  • Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
    cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
    Other Name: N/H.
Study Arms  ICMJE
  • Experimental: Everolimus Arm
    Everolimus Eluting Coronary Stent System
    Intervention: Drug: Everolimus Eluting Coronary Stent System
  • Active Comparator: non drug eluting stent Arm
    cobalt chromium balloon expandable stent
    Intervention: Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2014)
1504
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2009)
1500
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria

    • Patients presenting with a ST-elevation myocardial infarction <12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
    • Cardiogenic shock.
    • Rescue PCI after failed thrombolysis.
    • PCI indicated early (<24h) after effective thrombolysis following current ESC guidelines.
    • Patients presenting late ("latecomers") with ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms.
  • Written informed consent.
  • The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.

Angiographic:

  • Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.

Exclusion Criteria:

  • Age < 18 years.
  • Pregnancy or breastfeeding.
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
  • Patients with absolute indication of being chronic treated with acenocoumarol
  • Myocardial infarction due to a previously implanted stent thrombosis
  • Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00828087
Other Study ID Numbers  ICMJE EXAM-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sabate, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Spanish Society of Cardiology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof. P.W. Serruys, MD,PhD Erasmus MC, Rotterdam
Principal Investigator: Manuel Sabate, MD,PhD Hospital Clínic i Provincial de Barcelona
PRS Account Spanish Society of Cardiology
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP