NCT00704561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

June 24, 2008

Last Update Submit

May 17, 2022

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial InfarctionPercutaneous Coronary InterventionsOptical Coherence TomographyThrombus

Outcome Measures

Primary Outcomes (1)

  • Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent

    Non inferiority

    6 months

Secondary Outcomes (6)

  • number of well apposed stent struts without neointima

    6 months

  • number of malapposed stent struts without neointima

    6 months

  • number of sections with > 30% uncovered struts/total struts

    6 months

  • Number of sections with incomplete strut apposition

    6 months

  • Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

DES - Zotarolimus Drug eluting stents

ACTIVE COMPARATOR

Zotarolimus Drug eluting stents in overlap

Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)Device: Coronary stent implantation

BMS -Bare metal stent

ACTIVE COMPARATOR

Bare metal stent

Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)Device: Bare Metal Coronary Stent

Interventions

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

ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction

DES - Zotarolimus Drug eluting stents
DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)DEVICE

DRIVER bare metal stent implanted in acute myocardial infarction

BMS -Bare metal stent
Coronary stent implantationDEVICE

Comparison of Drug Eluting versus Bare Metal Stent

Also known as: Zotarolimus Eluting Coronary Stent
DES - Zotarolimus Drug eluting stents
Bare Metal Coronary StentDEVICE

Comaprison between Drug Eluting and Bare Metal Coronary Stents

Also known as: Driver Coronary Stent
BMS -Bare metal stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[≥ 3.75 mm in diameter\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

Related Publications (11)

  • Luscher 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. doi: 10.1161/CIRCULATIONAHA.106.675934.

    PMID: 17325255BACKGROUND

  • Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni 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. doi: 10.1016/S0140-6736(07)60314-6.

    PMID: 17321312BACKGROUND

  • Kindermann M, Adam O, Werner N, Bohm 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. doi: 10.1007/s00392-0591-z. Epub 2007 Oct 25.

    PMID: 17955157BACKGROUND

  • 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, Syvanne M, Suttorp MJ, Violini R, Schomig 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. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.

    PMID: 17901079BACKGROUND

  • 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. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

    PMID: 16814667BACKGROUND

  • 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. doi: 10.1016/j.amjcard.2007.08.020.

    PMID: 17950831BACKGROUND

  • 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. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.

    PMID: 16908773BACKGROUND

  • 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. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

    PMID: 17135281BACKGROUND

  • 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. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.

    PMID: 18307999BACKGROUND

  • 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. doi: 10.1161/CIRCULATIONAHA.107.752261. No abstract available.

    PMID: 18362244BACKGROUND

  • Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.

    PMID: 20630463DERIVED

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Giulio Guagliumi, MD

    Cardiovascular Department Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional cardiologist

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 25, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

IT(1)