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:
Collaborators:
Case Western Reserve University
Medtronic
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00704561
First received: June 24, 2008
Last updated: February 9, 2010
Last verified: March 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of well apposed stent struts without neointima [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • number of malapposed stent struts without neointima [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • number of sections with > 30% uncovered struts/total struts [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of sections with incomplete strut apposition [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • In segment OCT neontimal volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
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
Other Name: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
Device: Bare Metal Coronary Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents
Other Name: Driver Coronary Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Additional 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
Study First Received: June 24, 2008
Last Updated: February 9, 2010
Health Authority: Italy: Ethics Committee

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
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014