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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA) Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) Device: Coronary stent implantation Device: Bare Metal Coronary Stent Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: DES
Zotarolimus drug-eluting stent
 Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
Device: Coronary stent implantation
Comparison of Drug Eluting versus Bare Metal Stent
Other Name: Zotarolimus Eluting Coronary Stent
Active Comparator: BMS
bare metal stent
 Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
DRIVER bare metal stent implanted in acute myocardial infarction
Device: Bare Metal Coronary Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents
Other Name: Driver Coronary Stent


Outcome Measures
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Primary Outcome Measures :
  1. Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. number of well apposed stent struts without neointima [ Time Frame: 6 months ]
  2. number of malapposed stent struts without neointima [ Time Frame: 6 months ]
  3. number of sections with > 30% uncovered struts/total struts [ Time Frame: 6 months ]
  4. Number of sections with incomplete strut apposition [ Time Frame: 6 months ]
  5. Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) [ Time Frame: 6 months ]
  6. In segment OCT neontimal volume [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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])
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704561


Locations
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Case Western Reserve University
Medtronic
Investigators
Principal Investigator: Giulio Guagliumi, MD Cardiovascular Department Ospedali Riuniti di Bergamo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Giulio Guagliumi, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier: NCT00704561     History of Changes
Other Study ID Numbers: 457/2008
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: March 2009

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Acute Myocardial Infarction
Percutaneous Coronary Interventions
Optical Coherence Tomography
Thrombus

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs