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Six-month Coverage and Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography (OCTAMI)

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ClinicalTrials.gov Identifier: NCT00704561
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : February 10, 2010
Sponsor:
Collaborators:
Case Western Reserve University
Medtronic
Information provided by:
A.O. Ospedale Papa Giovanni XXIII

Tracking Information
First Submitted Date  ICMJE June 24, 2008
First Posted Date  ICMJE June 25, 2008
Last Update Posted Date February 10, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00704561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
  • number of well apposed stent struts without neointima [ Time Frame: 6 months ]
  • number of malapposed stent struts without neointima [ Time Frame: 6 months ]
  • number of sections with > 30% uncovered struts/total struts [ Time Frame: 6 months ]
  • Number of sections with incomplete strut apposition [ Time Frame: 6 months ]
  • Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) [ Time Frame: 6 months ]
  • In segment OCT neontimal volume [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Six-month Coverage and Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography
Official Title  ICMJE Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).
Brief Summary The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.
Detailed Description Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
    ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
  • Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
    DRIVER bare metal stent implanted in acute myocardial infarction
  • Device: Coronary stent implantation
    Comparison of Drug Eluting versus Bare Metal Stent
    Other Name: Zotarolimus Eluting Coronary Stent
  • Device: Bare Metal Coronary Stent
    Comaprison between Drug Eluting and Bare Metal Coronary Stents
    Other Name: Driver Coronary Stent
Study Arms  ICMJE
  • Active Comparator: DES
    Zotarolimus drug-eluting stent
    Interventions:
    • Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
    • Device: Coronary stent implantation
  • Active Comparator: BMS
    bare metal stent
    Interventions:
    • Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
    • Device: Bare Metal Coronary Stent
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 9, 2010)
44
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2008)
40
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset
  • Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)
  • Vessel size in between 2.5 and 3.75 mm
  • Signed patient informed consent

Exclusion Criteria:

  • Lesions in coronary artery bypass grafts
  • Significant left main disease
  • Killip class IV
  • Reecent major bleeding (6 months)
  • Renal failure with creatinine value > 2.5 mg/dl
  • Allergy to aspirin and or clopidogrel/ticlopidine
  • Patient in anticoagulant therapy
  • IMA due to a stent thrombosis
  • No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [≥ 3.75 mm in diameter])
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00704561
Other Study ID Numbers  ICMJE 457/2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giulio Guagliumi, Ospedali Riuniti di Bergamo
Study Sponsor  ICMJE A.O. Ospedale Papa Giovanni XXIII
Collaborators  ICMJE
  • Case Western Reserve University
  • Medtronic
Investigators  ICMJE
Principal Investigator: Giulio Guagliumi, MD Cardiovascular Department Ospedali Riuniti di Bergamo
PRS Account A.O. Ospedale Papa Giovanni XXIII
Verification Date March 2009

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