Optical Coherence Tomography
Assessment of gender diVersity
in primary Angioplasty
Plan for Success
GISE 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 & Motivation
Team & Methodology
Objectives & Timelines
Technology & 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 centers
 New model for rapid web-based image transfer
 Emphasis on real-time results
 Dedicated 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. Tuminello
R. Garbo
M. De Benedicts
G. Guagliumi
Centro Coordinatore
G. Tarantino
B. Reimers
S. Marra
M. Valgimigli
L. Vignali
G. Sangiorgi
C. Pierli
F. Saia
U. Limbruni
G. Trani
D. Capodanno
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Italian Steering Committee
B. Castiglioni
D. Trabattoni
G. Biondi Zoccai
M. Valgimigli
G. Trani
L. De Luca
F. Saia
O. Manfrini
Steering committee
Safety monitoring board
Medical reviewer
D. Capodanno
Statistical reviewer
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Int’l Scientific Board
Marco Costa
Ghada Mikhail
Chen Yundai
Takashi Akasaka
Elena Ladich
Renu Virmani
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Protocol Overview
Patients
140 STEMI patients  6 hrs
– 70 women
– 70 age-matched men
Enrollment
10 months
Procedures
Primary PCI with OCT pre and post
OCT at 9 months
Follow-up 12 months
Data
Fully electronic CRF and image management
International core labs
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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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Timelines
Total study duration: 2.5 years
Planning EC
Submissions
Startup
Study
Initiation
Recruitment
Completion
of Follow-up
Closeout
Final Report
Oct–Nov 2010
Dec 2010
Jan–Sept 2011
Dec 2012
Feb–Apr 2013
= Startup
= Active Study
= Completion
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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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MEDITRIAL for OCTAVIA
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
CatchTrial
Secure data tracking with CatchTrial
• High-speed web-based transfer of OCT raw data
• Automated, real time study analyses-reports
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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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MEDITRIAL for OCTAVIA
Step by Step
3°step
APPROVAZIONE RAPIDA
2°step
DOSSIER DELLO STUDIO
Conformità con
1°step
STRATEGIA
4°step
STARTUP e GESTIONE
Sottomissioni
complete ed
accurate
Stretto contatto
con i centri
Gestione per
•Reclutamento
veloce
•Controllo dati
•Verifica dei risultati
- Normative
- Procedure del centro
•Strategia per approvazione
rapida
•Selezione centri
•Selezione CRO team
•Pianificazione-budget
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MEDITRIAL for OCTAVIA
Support for Investigators
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MEDITRIAL for OCTAVIA
Behind the Scenes
Monica
Scientific
Barbara
Logistics
Rob
Communication
Rossella
Clinical
Alessio
Software
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Contacts
Meditrial Srl
Via Savoia 78, 00198 Roma
Tel. 06 45429780 – Fax 06 4542.9781
Barbara Pesce
[email protected]
Cell. 345.1500146
Monica Tocchi
[email protected]
Rob Meyerson
Cell. 393.1155344
Skype rob.meyerson
Rossella Mercuri
[email protected]
Alessio Ricciutelli
[email protected]
[email protected]
Cell. 335.6130262
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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
BERGAMO
20 October
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.
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Thank you
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