8:00 – 8:15 am

 ACADEMIA/INDUSTRY/FDA/NIH ROUNDTABLE ON ICH, CVD AND ICAD – OBJECTIVES                       

Location: Metropolitan Galleries 1-3

Chairs: Ajay Wakhloo, TUFTS University School of Medicine, USA
Adam Arthur, University of Tennessee, USA

Introduction: Marc Fisher, BIDMC/Harvard Medical School, USA

  8:15 – 11:00 am

SESSION 1: INTRACEREBRAL HEMORRHAGE (ICH) – NEW DATA, NEW LANDSCAPE, NEW APROACHES

Location: Metropolitan Galleries 1-3

Chairs: Mark Bain, Cleveland Clinic, USA
                Christopher Kellner, Mount Sinai, USA

8:15-8:35
Intracerebral Hemorrhage epidemiology
8:15 – 8:27 Presentation by Juhana Frösen, Tampere University and University Hospital Tampere, Finland
8:27 – 8:35 Comments by Jan- Karl Burkhardt, University of Pennsylvania, USA

8:35-8:55
Major ICH clinical trials
8:35 – 8:47 Presentation by Gustavo Pradilla, Emory University, USA
8:47 – 8:55 Comments by David Fiorella, Stony Brook University, USA

8:55-9:15
Current MIS Evacuation Techniques
8:55 – 9:07 Presentation by Christopher Kellner, Mount Sinai, USA
9:07 – 9:15 Comments by Brian Jankowitz, JFK University Medical Center Edison, USA

9:15-9:35
Novel technologies
9:15 – 9:27 Presentation by Mark Bain, Cleveland Clinic, USA
9:27 – 9:35 Comments by J Mocco, Mount Sinai Health System, USA

09:35 – 11:00 ROUNDTABLE PANEL DISCUSSION
Panelists:
Mark Bain, Cleveland Clinic, USA; Christopehr Kellner, Mount Sinai, USA; J Mocco, Mount Sinai Health System, USA; David Fiorella, Stony Brook University, USA; Jan- Karl Burkhardt, University of Pennsylvania, USA; Juhana Frösen, Tampere University and University Hospital Tampere, Finland; Babu Welch, UT Southwestern Medical Center, USA

  11:15 am– 1:30 pm

SESSION 2:  CEREBRAL VENOUS DISEASES: NEW DATA, NEW LANDSCAPE, NEW APROACHES

Location: Metropolitan Galleries 1-3

Chairs: Vitor Pereira, University of Toronto and St. Michael’s Hospital, Canada
Felipe Alburquerque, Barrow Neurological Institute, USA

11:15 -11:35
Overview of cerebral Venopathies
11:15 – 11:27 Presentation by Felipe Albuquerque, Barrow Neurological Institute, USA
11:27 – 11:35 Comments by Dorothea Altschul, The Valley Hospital, USA

11:35-11:55
Cerebral Phlebography – what should we be looking for?
11:35 – 11:47 Presentation by Omar Choudhri, University of Pennsylvania, USA
11:47 – 11:53 Comments by Waleed Brinjikji, Mayo Clinic, USA

11:55- 12:15
Cerebral Venopathies – management options
11:55 – 12:07 Presentation by Vitor Pereira, University of Toronto and St. Michael’s Hospital, Canada
12:07 – 12:15 Comments by Peter Kan, The University of Texas Medical Branch, USA

12:15 – 12:35
Clinical trial designs – what is next?
12:15 – 12:27 Presentation by Kyle Fargen, Atrium Health Wake Forest Baptist Medical Center, USA
12:27 – 12:35 Comments by Athos Patsalides, North Shore University Hospital, USA

12:35 – 1:30 ROUNDTABLE PANEL DISCUSSION
Vitor Pereira, University of Toronto and St. Michael’s Hospital, Canada; Felipe Alburquerque, Barrow Neurological Institute, USA; Gabor Toth, Cleveland Clinic, USA; David Liebeskind, UCLA, USA; Pierre Gobin, Cornell University, USA; Athos Patsalides, North Shore University Hospital, USA; Waleed Brinjikji, Mayo Clinic, USA; Ferdinand Hui, University of Hawaii, USA;

  2:30 – 5:00 pm

SESSION 3: INTRACRANIAL ATHEROCCLUSIVE DISEASE (ICAD): NEW DATA, NEW LANDSCAPE, NEW APROACHES

Location: Metropolitan Galleries 1-3

Chairs:  Brian Hoh, University of Florida, USA
Raul Nogueira, University of Pittsburgh, USA

2:30- 2:50
Do we know more after SAMMPRIS/VISSIT what went right, what went wrong?
2:30 – 2:42 Presentation by Sam Zaidat, Mercy Health St Vincent, USA
2:42 – 2:50 Comments by Raul Nogueira, University of Pittsburgh, USA

2:50-3:10
Role of surgery in ICAD

2:50 – 3:02 Presentation by Sepideh Amin-Hanjani, University Hospitals Cleveland Medical Center, USA
3:02 – 3:10 Comments by Giuseppe Lanzino, Mayo Clinic, USA

3:10-3:30
Endovascular Management of ICAD

3:10 – 3:22 Presentation by Pedro Lylyk, University of Buenos Aires, USA
3:22 – 3:30 Comments by Demetrius Lopes, Advocate Aurora Health, USA

3:30-3:50 Imaging of ICAD

3:30 – 3:42 Presentation by Matthew J Gounis, UMass Chan Medical School, USA
3:42 – 3:50 Comments by Edgar Samaniego, University of Iowa, Iowa City, USA     

3:50-4:10
Modern Management of ICAD – What we know and what we must learn

3:50 – 4:02 Presentation by Brian Hoh, University of Florida, USA
4:02 – 4:10 Comments by Fawaz Al-Mufti, New York Medical College, USA

4:10 – 5:00 ROUNDTABLE PANEL DISCUSSION
Brian Hoh, University of Florida, USA; Raul Nogueira, University of Pittsburgh, USA; Sepideh Amin-Hanjani, University Hospitals Cleveland Medical Center, USA; Fawaz Al-Mufti, New York Medical College, USA; Satoshi Tateshima, UCLA, USA; Italo Linfante, Miami Neuroscience Institute, USA; Ali Sultan, Harvard Medical School, USA; Geoffrey Colby, University of California, US;

  5:15 – 6:15 pm

SESSION 4: REGULATORY PERSPECTIVE ON KEY CLINICAL TRIAL ISSUES

Location: Metropolitan Galleries 1-3

Chairs: Adnan Siddiqui, State University of New York, USA;
Ricardo Hanel, Baptist Health, USA;
Xiaolin (Lin) Zheng, FDA, USA

5:15–5:35 FROM BENCH TO FIRST-IN-HUMAN: WHAT IS NEEDED FOR AN EARLY FEASIBILITY STUDY IDE?
Xiaolin (Lin) Zheng, FDA, USA

• Understanding the transition from bench research to the initial stages of human trials.
• Identifying the critical elements required to initiate Early Feasibility Study IDEs in the U.S.
• FDA Panel (CDER & CDRH) Answers to Stroke Community Questions

5:35 – 6:15
ROUNDTABLE PANEL DISCUSSION
Panelists:
Adnan Siddiqui, State University of New York, USA; Philipp Taussky, BIDMC/Harvard Medical School, USA; Ricardo Hanel, Baptist Health, USA; Guilherme Dabus, Miami Cardiac and Vascular Institute and Baptist Neuroscience Institute, USA; David Altschul, Montefiore Medical Center, USA; Adel Malek, Tufts Medical Center, USA; Xiaolin (Lin) Zheng, FDA, USA; Gabriela Suarez-Mier, FDA, USA; Amy Smith, MicroVention, USA