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

Sponsors and Collaborators:	Ospedali Riuniti di Bergamo Case Western Reserve University Medtronic
Information provided by:	Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:	NCT00704561

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)	Phase III

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Ospedali Riuniti di Bergamo:

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 ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Zotarolimus drug-eluting stent	Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA) ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
2: Active Comparator bare metal stent	Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) DRIVER bare metal stent implanted in acute myocardial infarction

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704561

Contacts

Contact: Monia Lorini, MD

39-035-269-751

mlorini@ospedaliriuniti.bergamo.it

Locations

Italy
Ospedali Riuniti di Bergamo	Recruiting
Bergamo, Italy
Contact: Giulio Guagliumi, MD 39-035-266-455 guagliumig@interfree.it
Contact: Giuseppe Musumeci, MD 39-035-266-455 giuseppe.musumeci@gmail.it

Sponsors and Collaborators

Ospedali Riuniti di Bergamo

Case Western Reserve University

Medtronic

Investigators

Principal Investigator:

Giulio Guagliumi, MD

Cardiovascular Department Ospedali Riuniti di Bergamo

More Information

Publications:

Lüscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007 Feb 27;115(8):1051-8. Review.

Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78.

Kindermann M, Adam O, Werner N, Böhm M. Clinical Trial Updates and Hotline Sessions presented at the European Society of Cardiology Congress 2007: (FINESSE, CARESS, OASIS 5, PRAGUE-8, OPTIMIST, GRACE, STEEPLE, SCAAR, STRATEGY, DANAMI-2, ExTRACT-TIMI-25, ISAR-REACT 2, ACUITY, ALOFT, 3CPO, PROSPECT, EVEREST, COACH, BENEFiT, MERLIN-TIMI 36, SEARCH-MI, ADVANCE, WENBIT, EUROASPIRE I-III, ARISE, getABI, RIO). Clin Res Cardiol. 2007 Nov;96(11):767-86. Epub 2007 Oct 25.

Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvänne M, Suttorp MJ, Violini R, Schömig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. Epub 2007 Sep 27.

Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. Epub 2006 May 5.

Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. Review.

Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. Epub 2006 Aug 14.

Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. Epub 2006 Nov 29.

Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. Epub 2008 Jan 10.

Pinto Slottow TL, Waksman R. Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on the endeavor zotarolimus-eluting coronary stent. Circulation. 2008 Mar 25;117(12):1603-8. No abstract available.

Responsible Party:	Ospedali Riuniti di Bergamo ( Giulio Guagliumi )
Study ID Numbers:	457/2008
Study First Received:	June 24, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00704561
Health Authority:	Italy: Ethics Committee

Keywords provided by Ospedali Riuniti di Bergamo:

Acute Myocardial Infarction
Percutaneous Coronary Interventions
Optical Coherence Tomography
Thrombus

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction
Thrombosis

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009