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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704561
First Posted: June 25, 2008
Last Update Posted: February 10, 2010
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.
Collaborators:
Case Western Reserve University
Medtronic
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
June 24, 2008
June 25, 2008
February 10, 2010
April 2008
April 2009   (Final data collection date for primary outcome measure)
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00704561 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Six-month Coverage and Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography
Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2009
April 2009   (Final data collection date for primary outcome measure)

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])
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00704561
457/2008
Yes
Not Provided
Not Provided
Giulio Guagliumi, Ospedali Riuniti di Bergamo
A.O. Ospedale Papa Giovanni XXIII
  • Case Western Reserve University
  • Medtronic
Principal Investigator: Giulio Guagliumi, MD Cardiovascular Department Ospedali Riuniti di Bergamo
A.O. Ospedale Papa Giovanni XXIII
March 2009

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