Early Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 24, 2008

Last Updated Date

June 24, 2008

Start Date ^†

April 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Early Coverage and Vessel Wall Response of the Zotarolimus Drug-Eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

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).

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Acute Myocardial Infarction

Intervention ^†

Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)

Study Arms / Comparison Groups

Active Comparator: Zotarolimus drug-eluting stent
Active Comparator: bare metal stent

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

September 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

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])

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Monia Lorini, MD

39-035-269-751

mlorini@ospedaliriuniti.bergamo.it

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00704561

Responsible Party

Giulio Guagliumi, Ospedali Riuniti di Bergamo

Secondary IDs ^††

Study Sponsor ^†

Ospedali Riuniti di Bergamo

Collaborators ^††

Case Western Reserve University
Medtronic

Investigators ^†

Principal Investigator:

Giulio Guagliumi, MD

Cardiovascular Department Ospedali Riuniti di Bergamo

Information Provided By

Ospedali Riuniti di Bergamo

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.