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
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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 |
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 |

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 |
- Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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])

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
Italy | |
Ospedali Riuniti di Bergamo | |
Bergamo, Italy |
Principal Investigator: | Giulio Guagliumi, MD | Cardiovascular Department Ospedali Riuniti di Bergamo |
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 |
Acute Myocardial Infarction Percutaneous Coronary Interventions Optical Coherence Tomography Thrombus |
Myocardial Infarction 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 |