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Acute Myocardial InfarctionOCTAMINCT00704561

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

A study testing ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA), DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) and Coronary stent implantation in people with Acute Myocardial Infarction, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA), DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) and Coronary stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteItaly
Study dates
Apr 2008to Oct 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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])

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedali Riuniti di Bergamo

    Bergamo

Other trials in Italy

About this 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).

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.

Read the 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.

Being tested
ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA), DRIVER bare metal stent (Medtronic, Santa Rosa, Ca), Coronary stent implantation, Bare Metal Coronary Stent
Keywords
Acute Myocardial Infarction, Percutaneous Coronary Interventions, Optical Coherence Tomography, Thrombus
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction

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

    DRIVER bare metal stent implanted in acute myocardial infarction

  • Coronary stent implantationDevice

    Also called Zotarolimus Eluting Coronary Stent

    Comparison of Drug Eluting versus Bare Metal Stent

  • Bare Metal Coronary StentDevice

    Also called Driver Coronary Stent

    Comaprison between Drug Eluting and Bare Metal Coronary Stents

Study groups in NCT00704561
Study groupRoleWhat they receive
DES - Zotarolimus Drug eluting stentsActive comparatorZotarolimus Drug eluting stents in overlap
Receives: Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA); Device: Coronary stent implantation
BMS -Bare metal stentActive comparatorBare metal stent
Receives: Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca); Device: Bare Metal Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Non inferiority

    Measured: 6 months

Secondary outcomes (6)

  1. number of well apposed stent struts without neointima

    number of well apposed stent struts without neointima

    Measured: 6 months

  2. number of malapposed stent struts without neointima

    number of malapposed stent struts without neointima

    Measured: 6 months

  3. number of sections with > 30% uncovered struts/total struts

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

    Measured: 6 months

  4. Number of sections with incomplete strut apposition

    Number of sections with incomplete strut apposition

    Measured: 6 months

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

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

    Measured: 6 months

  6. In segment OCT neontimal volume

    In segment OCT neontimal volume

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704561
Sponsor's protocol ID
457/2008
Acronym
OCTAMI
Status last verified
May 2022
First submitted
24 Jun 2008
Last updated
23 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17325255

  • 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.

    PubMed 17321312

  • 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.

    PubMed 17955157

  • 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.

    PubMed 17901079

  • 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.

    PubMed 16814667

  • 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.

    PubMed 17950831

  • 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.

    PubMed 16908773

  • 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.

    PubMed 17135281

  • 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.

    PubMed 18307999

  • 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.

    PubMed 18362244

  • 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.

    PubMed 20630463

Questions about this trial

What is this clinical trial studying?

A study testing ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA), DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) and Coronary stent implantation in people with Acute Myocardial Infarction, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00704561, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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