Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

NCT ID: NCT00704561

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-10-31

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DES - Zotarolimus Drug eluting stents

Zotarolimus Drug eluting stents in overlap

Group Type: ACTIVE_COMPARATOR

ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)

Intervention Type: DEVICE

ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction

Coronary stent implantation

Intervention Type: DEVICE

Comparison of Drug Eluting versus Bare Metal Stent

BMS -Bare metal stent

Bare metal stent

Group Type: ACTIVE_COMPARATOR

DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)

Intervention Type: DEVICE

DRIVER bare metal stent implanted in acute myocardial infarction

Bare Metal Coronary Stent

Intervention Type: DEVICE

Comaprison between Drug Eluting and Bare Metal Coronary Stents

Interventions

ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)

ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction

Intervention Type: DEVICE

DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)

DRIVER bare metal stent implanted in acute myocardial infarction

Intervention Type: DEVICE

Coronary stent implantation

Comparison of Drug Eluting versus Bare Metal Stent

Intervention Type: DEVICE

Bare Metal Coronary Stent

Comaprison between Drug Eluting and Bare Metal Coronary Stents

Intervention Type: DEVICE

Other Intervention Names

Zotarolimus Eluting Coronary Stent; Driver Coronary Stent

Eligibility 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])

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role: lead

Responsible Party

Giulio Guagliumi

Interventional cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulio Guagliumi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Department Ospedali Riuniti di Bergamo

Locations

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Countries

Italy

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Other Identifiers

457/2008

Identifier Type: -

Identifier Source: org_study_id