Optical Coherence TomographyAssessment of gender diVersityin primary Angioplasty

Plan for SuccessGISE Congress, Genova, 17 Oct. 2010

Today’s Presentation

The objective, methodologies and technological tools of the OCTAVIA trial represent an innovation for Italian and international research

Today we will discuss the study’s:Background & MotivationTeam & MethodologyObjectives & TimelinesTechnology & Communication

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About OCTAVIA

OCTAVIA will help resolve important unanswered questions that lead to better care for women with coronary heart disease

AND is also unique because…First national cooperation of leading OCT centersNew model for rapid web-based image transferEmphasis on real-time resultsDedicated communication tools

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Meet the OCTAVIA Team

Scientific promoter• The Italian Society of

Interventional Cardiology (GISE)

Study coordinator• Dr. Giulio Guagliumi, recognized worldwide as

an opinion leader for coronary OCT

 

Study centers• Fifteen OCT centers across Italy

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OCTAVIA Study Centers

G. GuagliumiCentro Coordinatore

M. Valgimigli

G. Trani

C. Pierli

B. Reimers

R. Garbo

G. Sangiorgi

D. Capodanno

G. Tarantino

U. Limbruni

M. De Benedicts

F. Saia

L. Vignali

S. Marra

G. Tuminello

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Italian Steering Committee

D. Trabattoni

M. Valgimigli

G. Trani

F. Saia

D. Capodanno

L. De Luca

G. Biondi Zoccai

O. Manfrini

B. Castiglioni

Steering committeeSafety monitoring boardMedical reviewerStatistical reviewer

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Int’l Scientific Board

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Ghada Mikhail

Elena Ladich

Renu Virmani

Marco Costa Chen Yundai Takashi Akasaka

Protocol OverviewPatients

140 STEMI patients 6 hrs– 70 women– 70 age-matched men

ProceduresPrimary PCI with OCT pre and postOCT at 9 monthsFollow-up 12 months

DataFully electronic CRF and image managementInternational core labs

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Enrollment10 months

Methodology

QCA, OCT and histological thrombus analysis• Shed light on the underlying mechanisms of

coronary thrombosis in women

• International core labs, blinded analysis

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Total study duration: 2.5 years

Timelines

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Planning EC Submissions

Startup Study Initiation

RecruitmentCompletion of

Follow-upCloseout Final

Report

Oct–Nov 2010 Dec 2010 Jan–Sept 2011 Dec 2012 Feb–Apr 2013

= Startup

= Active Study

= Completion

Research Organization

More trial, less error.• OCTAVIA is overseen by

Meditrial, a contract research organization specializing in device trials.

• We offer expertise and advanced technology, all within a streamlined model that seeks to eliminate wasted time and resources.

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Complete Management

1. Strategic program

2. CatchTrial: data collection/analysis and electronic images

3. Startup, management, monitoring

4. Communication: logo, website, newsletter

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MEDITRIAL for OCTAVIA

CatchTrialSecure data tracking with CatchTrial• High-speed web-based transfer of OCT raw data• Automated, real time study analyses-reports

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MEDITRIAL for OCTAVIA

CatchTrial IMAGES Speed

Maximal speed with proprietary software for rapid upload/download.

Upload speed: raw OCT data in 30-60 min*

Download speed: 5 min*

You can normally use the PC during image transfer.* Standard ADSL connection

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Real-time Study Progress

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Easy Safety Tracking

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Rapid Endpoint Assessment

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Catchtrial for Octavia• Creation of tables replicating published articles• Real-time results as data are entered by sites

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4°stepSTARTUP e GESTIONE

4°stepSTARTUP e GESTIONE3°step

APPROVAZIONE RAPIDA 3°step

APPROVAZIONE RAPIDA

2°stepDOSSIER DELLO STUDIO

2°stepDOSSIER DELLO STUDIO

1°stepSTRATEGIA

1°stepSTRATEGIA

Step by Step

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MEDITRIAL for OCTAVIA

Support for Investigators

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MEDITRIAL for OCTAVIA

RossellaClinical

AlessioSoftware

MonicaScientific

Rob Communication

BarbaraLogistics

Behind the Scenes

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MEDITRIAL for OCTAVIA

Contacts

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Meditrial SrlVia Savoia 78, 00198 RomaTel. 06 45429780 – Fax 06 4542.9781

Monica Tocchim.tocchi@meditrial.euCell. 393.1155344

Rossella Mercurir.mercuri@meditrial.euCell. 335.6130262

Barbara Pesceb.pesce@meditrial.euCell. 345.1500146

Rob Meyersonr.meyerson@meditrialeurope.comSkype rob.meyerson

Alessio Ricciutellihelpdesk@catchtrial.com

In Summary• This important study represents an opportunity

for the Italian interventional community to set a new model of collaboration, quality and efficiency

• The main challenges ahead are the approval process and patient recruitment

• Next step: collaboration for quick approval

• TARGET STUDY STARTUP: January 2011

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EC submission plan

Center EC Deadline Center EC Deadline

S. Giovanni TO 1 Nov. Parma 12 Nov.

Bologna 2-4 Nov. Padova 13 Nov.

Gemelli RM 4 Nov. Siena 15 Nov.

Mirano VE 4 Nov. Mauriziano TO 20 Nov.

Modena 4 Nov. Molinette TO 25 Nov.

Ferrara 5 Nov. Asti 26 Nov.

Ferrarotto CT 6 Nov. Grosseto 30 Nov.

BERGAMO 20 October

Thank you

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