Study concept and design: Zaidat, Gress.
Acquisition, analysis, or interpretation of data: Zaidat, Fitzsimmons, Woodward, Killer-Oberpfalzer, Wakhloo, Gupta, Kirshner, Megerian, Lesko, Pitzer, Ramos, Castonguay, Barnwell, Smith, Gress.
Drafting of the manuscript: Zaidat, Megerian, Ramos, Castonguay.
Critical revision of the manuscript for important intellectual content: Zaidat, Fitzsimmons, Woodward, Killer-Oberpfalzer, Wakhloo, Gupta, Kirshner, Megerian, Lesko, Pitzer, Ramos, Castonguay, Barnwell, Smith, Gress.
Statistical analysis: Woodward, Megerian, Lesko.
Obtained funding: Woodward, Megerian.
Administrative, technical, or material support: Fitzsimmons, Woodward, Wakhloo, Gupta, Megerian, Ramos, Castonguay, Barnwell, Gress.
Study supervision: Zaidat, Woodward, Killer-Oberpfalzer, Kirshner, Megerian, Pitzer.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Zaidat reported serving as a compensated consultant for Codman & Shurtleff. Dr Gupta reports personal fees from Stryker Neurovascular during the conduct of the study; personal fees from Rapid Medical, and personal fees from Covidien outside the submitted work. Drs Megerian, Lesko, Mss Pitzer and Ramos report being Codman & Shurtleff clinical employees. Dr Smith reports receipt of compensation from Johnson and Johnson for service as a data and safety monitoring board (DSMB) member. Dr Gress reports receipt of compensation from Johnson and Johnson for service as a DSMB member. No other disclosures were reported.
Independent DSMB: Daryl R. Gress, MD (chairman), Wade S. Smith, MD, PhD, Philip M. White, MD, Stanley Barnwell, MD, and Misha Eliasziw, PhD.
Site Investigators Top 6 Enrolling Sites: Osama O. Zaidat (PI), Brian-Fred Fitzsimmons, John R. Lynch, Alicia C. Castonguay, and Mohammad A. Issa, Medical College of Wisconsin/Froedtert Hospital, Wauwatosa; Britton Keith Woodward, primary investigator (PI), T. Darrell Thomas, Donald Gregory Wheatley, Carla Staruk, Vista Radiology, Knoxville, TN; Zhi-gang Wang (PI), Yihua Wang, Cheng-wei Wang, The Second Hospital of Shangdong University, Ji’nan China; Monika Killer-Oberpfalzer (PI), Erasmia Broussalis, and Angela Jeditschka, Paracelsus Medical University, Christian Doppler Clinic, Salzburg, Austria; Ajay Wakhloo (PI), Majas Moonis, Mohamed Ramzen, Chalene Franz, Eileen Duhamel, Alicia Hill, and Barbara Glidden, University of Massachusetts, Worcester; Rishi Gupta, Howard Kirshner (PI), John Connors, Anne O'Duffy, Robert Singer, and Diane Brown, Vanderbilt University Medical Center, Nashville, TN.
Site Investigators Other Enrolling Sites: Elad Levy (PI), Adnan H. Siddiqui, Mary Hartney, Dawn Holler, and Maureen Donovan, University at Buffalo, Buffalo, NY; Ketan Bulsara (PI), Yale University School of Medicine, Hartford, CT; Michel Mawad (PI), Hesham Morsi, Hashem Shaltoni, Jose Suarez, Eric Bershad, Sheila Moore, Gilberto De Freitas, and Venkatasubba Rao, Baylor College of Medicine, Houston, TX; Donald Larsen (PI), William Mack, Arun P. Amar, Nerses Sanossian, Matthew Tenser, Mary Anne Kim, Gene Sung, Benjamin Emanuel, and Kelly Vecchiarelli, USC and LAC/Health Research Association, Los Angeles, CA; Guo-Dong Gao (PI), Zhenwei Zhao, Jianping Deng, and Jia Yu, The Fourth Military Hospital, Tangdu Hospital, Xi’An, China; Italo Linfante (PI) and Sarah Orrendorf-Alegre, Baptist Cardiac and Vascular Institute, Miami, FL; Bernard Bendok (PI), Richard Bernstein, Michael Hurley, and Sameer Ansari, Northwestern Medical Faculty Foundation, Chicago, IL; Timothy Malisch (PI), Franklin Marden, and Virginia Reilly, Alexian Brothers Medical Center, Elk Grove Village, IL; Ling Fing (PI), Liqun Jiao, and Yan Ma, Capital Medical University, Xuanwu Hospital, Beijing, China; Alan Boulos (PI), John Dalfino, Bernadette Barnum, and Linda Graca, Albany Medical Center, Albany, NY; Alex Abou-Chebl (PI), Kerri Remmel, Anand Vaishnav, Vincent Troung, Anne Jerde, Angela Siegwald, Elizabeth Wise, Kari Moore, and Lesha Blakey, University of Louisville, Louisville, KY; Randall Edgell, Jacon Kitchner, Ritesh Kaushal, Sonal Mehta, Nirav Vora, Eli Feen, Surasak Komonchan, Amer Alshekhlee, Salvador Cruz-Flores, Paisith Piriyawat, Eve Holzemer, AnneMarie Fann, and Susan Eller, St. Louis University, St. Louis, MO; Alison Nohara (PI), Brian Kott, Dennis Wang, Debora Watkins, and Christine Biljan, Franciscan Research Center, Tacoma, WA; Ricardo Hanel (PI), David Miller, Kevin Barret, William Freeman, James Meschia, Benjamin Eidelman, Dale Gamble, and Sothear Luke, Mayo Clinic, Jacksonville, FL; Beverly Aagaard-Kienitz (PI), Matt Jensen, Justin Sattin, David Niemann, and Lori Wollet, University of Wisconsin, Madison; Johanna Fifi (PI), Alejandro Berenstein, Raphael Ortiz, Nimi Yasunari, Nimi Yasunari, and Ahmed Otokiti, Roosevelt Hospital, New York, NY; Andrew Xavier (PI), Sandra Narayanan, Lynn Boomer, Ann Quail, and Susan Oblak, St. Joseph’s Mercy, Pontiac, MI; Adel M. Malek (PI), Tufts Medical Center, Boston, MA; Louis Kim (PI), Basavaraj Ghodke, Laligam Sekhar, Kyra Becker, and Patricia Tanzi, Harborview Medical Center, Seattle, WA; Akram Shhadeh (PI), Steven Hoover, and Bradley Hightower, The University of Oklahoma Health Sciences Center, Oklahoma City; Michael Marks (PI), Robert Dodd, Huy Minh Do, Mary Marcellus, Bianca Moiseff, and Maria Coburn, Stanford Medical Center, Stanford, CA.
Funding/Support: The trial was initiated and funded by Micrus Endovascular.
Role of the Funder/Sponsor: Micrus Endovascular and Codman & Shurtleff were involved in the design and conduct of the study; and the collection, management, analysis, and interpretation of the data. The sponsor reviewed the manuscript and provided comments to the authors before submission, but did not require any changes to the manuscript. Other than the sponsor employees who were included among the study authors, the sponsor had no role in the decision to submit the manuscript for publication. The trial was designed by the initial sponsor: the Micrus internal medical team with an advisory group of vascular neurologists, neurointerventionalists, and neurointensivists on an as-needed basis and in person meeting prior to the trial initiation. Codman & Shurtleff, Inc, subsequently acquired Micrus and made an internal decision to conduct unplanned analysis, given the results of the SAMMPRIS trial and halted the study.
Additional Contributions: Dr Zaidat received no financial compensation for the manuscript drafting or his role with the initial company advisor (Micrus).