8:00 – 8:15 am

INAUGURATION OF ACADEMIA/INDUSTRY/FDA/NIH ROUNDTABLE ON BRAIN ANEURYSM, BRAIN AVM AND CHRONIC SDH – OBJECTIVES

South Ballroom

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: BRAIN ANEURYSMS – NEW DATA, NEW LANDSCAPE, NEW APROACHES

South Ballroom

Chairs: Stavropoula Tjoumakaris, Thomas Jefferson University, USA
J Mocco, Mount Sinai Health System, USA

8:15 – 8:35
Unruptured and ruptured aneurysms. What do we really know?
8:15- 8:27 Presentation by Juhana Frösen, Tampere University and University Hospital Tampere, Finland
8:27 -8:35 Comments by Giuseppe Lanzino, Mayo Clinic, USA

8:35 – 8:55
Aneurysm management options
8:35 – 8:47 Presentation by Howard Riina, NYU Langone Health, USA
8:47 – 8:55 Comments by Michael Lawton, Barrow Neurological Institute, USA

8:55 – 9:15
Unruptured aneurysms: clinical trials
8:55 – 9:07 Presentation by Vitor Pereira, University of Toronto and St. Michael’s Hospital, Canada
9:07 – 9:15 Comments by Alexander Coon, Carondelet Neurological Institute, USA

9:15 – 9:35
Ruptured aneurysms: clinical trials
9:15 – 9:27 Presentation by David Hasan, Duke University School of Medicine, USA
9:27 – 9:35 Comments by Philipp Taussky, BIDMC/Harvard Medical School, USA

9:35 – 9:55
Novel Device Technologies for Aneurysms. Preclinical system models and how should they be tested
9:35 – 9:47 Presentation by Matthew Gounis, UMass Chan Medical School, USA
9:47 – 9:55 Comments by Barry B Lieber, Tufts University School of Medicine/ Lahey Hospital & Medical Center, USA

10:00 – 11:00 ROUNDTABLE PANEL DISCUSSION
Panelists:
Stavropoula Tjoumakaris, Thomas Jefferson University, USA; J Mocco, Mount Sinai Health System, USA; David Liebeskind, UCLA, USA; Michael Froehler, Vanderbilt University Medical Center, USA; John Daniel, Stryker, USA; Patrick Noonan, FDA, USA; James Koenig, NIH, USA; Jacques Dion, MicroVention, USA; Luis Morales, Medtronic, USA

  11:15 am– 1:30 pm

SESSION 2: cSDH: NEW DATA, NEW LANDSCAPE, NEW APROACHES

South Ballroom

Chairs: Alexander Khalessi, UC San Diego Health, USA
Mark Bain, Cleveland Clinic, USA

11:15 – 11:30
What do we know about cSDH?
11:15 – 11:23 Presentation by Peter Kan, The University of Texas Medical Branch, USA
11:23 – 11:30 Comments by Adam Arthur, University of Tennessee, USA

11:30 – 11:45
cSDH clinical trials – what should we be looking for?
11:30 – 11:38 Presentation by David Fiorella, Stony Brook University, USA
11:38 – 11:45 Comments by Babu Welch, UT Southwestern Medical Center, USA

11:45 – 12:00
cSDH management options
11:45 – 11:53 Presentation by Geoffrey Colby, University of California, USA
11:53 – 12:00 Comments by Ali Sultan, Harvard Medical School, USA

12:00 – 12:15
Novel management for cSDH – what is next?
12:00 – 12:08 Presentation by Ricardo Hanel, Baptist Health, USA
12:08 – 12:15 Comments by Gabor Toth, Cleveland Clinic, USA

12:15 – 1:30
ROUNDTABLE PANEL DISCUSSION
Panelists:
Alexander Khalessi, UC San Diego Health, USA; Mark Bain, Cleveland Clinic, USA; Gabor Toth, Cleveland Clinic, USA; Adam Arthur, University of Tennessee, USA; David Liebeskind, UCLA, USA; William (Bill) Ashley, FDA, USA; Chris Loftus, FDA, USA; Patrick Brouwer, JNJ Cerenovus,USA; Jacques Dion, MicroVention, USA; Kara Madsen, Medtronic, USA

  2:30 – 4:30 pm

SESSION 3: bAVM: NEW DATA, NEW LANDSCAPE, NEW APROACHES

South Ballroom

Chairs:  Michael Marks, Stanford University School of Medicine, USA
Satoshi Tateshima, UCLA, USA

2:30 – 2:45 Do we know more after ARUBA?
2:30 – 2:40 Presentation by Victor Volovici, Erasmus Medical Center, The Netherlands
2:40 – 2:45 Comments by Darren Orbach, Harvard Medical School & Boston Children’s Hospital, USA

2:45 – 3:00 Do we need new AVM trials and how to design new AVM trials?
2:45 – 2:55 Presentation by Philip Meyers, Columbia University, USA
2:55 – 3:00 Comments by Sandra Narayanan, Pacific Neuroscience Institute, USA

3:00 – 3:15
Surgical and Endovascular Management of Brain AVM
3:00 – 3:10 Presentation by Brian Hoh, University of Florida, USA
3: 10 – 3:15 Comments by Alejandro Berenstein, Mount Sinai Health System, USA

3:15 – 3:30
Are there useful preclinical models?
3:15 – 3:25 Presentation by Johanna Fifi, The Mount Sinai Hospital, USA
3:25 – 3:30 Comments by Ajay Wakhloo, TUFTS University School of Medicine, USA

3:30 – 3:45 How should we manage bAVM in the post ARUBA etc.?
3:30 – 3:40 Presentation by Fady Charbel, University of Illinois Chicago, USA
3:40 – 3:45 Comments by Michael Lawton, Barrow Neurological Institute, USA

3:45 – 4:30 ROUNDTABLE PANEL DISCUSSION
Panelists:
Michael Marks, Stanford University, USA; Satoshi Tateshima, UCLA, USA; Ali Sultan, Harvard Medical School, USA; Michael Lawton, Barrow Neurological Institute, USA; Fernando Gonzalez, The Johns Hopkins Hospital, USA, John Marler, FDA, USA, Patrick Brouwer, JNJ Cerenovus,USA

  4:45 – 6:15 pm

SESSION 4: REGULATORY PERSPECTIVE ON KEY CLINICAL TRIAL ISSUES

South Ballroom

Chairs: Adnan Siddiqui, State University of New York, USA
Adel Malek, Tufts Medical Center, USA
Xiaolin (Lin) Zheng, FDA, USA

4:45 – 5:10
Presentation by Xiaolin (Lin) Zheng, FDA, USA

• New Approaches / Structure at the FDA
• New and Known Approaches to Collecting Safety and Effectiveness Data in Clinical Studies
• FDA Panel (CDER & CDRH) Answers to Stroke Community Questions

5:10 – 6:15
ROUNDTABLE PANEL DISCUSSION
Panelists:
Adnan Siddiqui, State University of New York, USA; Adel Malek, Tufts Medical Center, USA; Xiaolin (Lin) Zheng, FDA, USA; Fady Charbel, University of Illinois Chicago, USA; Michael Froehler, Vanderbilt University Medical Center, USA; David Altschul, Montefiore Medical Center, USA; Jennifer Mateus, Stryker, USA; Jeremy Brown, NIH-NINDS, USA

  7:30 – 9:30 pm

DINNER FOLLOWED BY А SPECIAL PRESENTATION

Galaxy Ballroom

Introduction: Michael Lawton, Barrow Neurological Institute, USA
Ajay Wakhloo, TUFTS University School of Medicine, USA

My personal journey as a cerebrovascular surgeon
Robert F Spetzler, Barrow Neurological Institute, USA