Standardized End Point Definitions for Clinical Trials in Thoracic Aortic Repair: A Consensus Report From the ARCH–Academic Research Consortium
Abstract
Innovation in the treatment of ascending aorta and arch pathology with novel catheter-based and hybrid procedures has driven the need for a strategy to guide their safe application. The ARCH-ARC (Aortic Arch Academic Research Consortium) was established to pragmatically develop consistent clinical end points and to standardize definitions for use in studies of these new technologies. The ARCH-ARC team, consisting of independent international specialists in cardiac surgery, vascular surgery, vascular medicine, cardiology, neurology, radiology, and clinical trials, along with US Food and Drug Administration, industry, and contract research organization representatives, held virtual meetings from 2021 to 2025. Consensus was used to identify appropriate clinical end points and to standardize definitions of end points for endovascular, hybrid, and open surgical procedures in clinical trials in the ascending aorta and arch. Drawing on previous ARC work in cardiac, neurological, renal, and bleeding end points, the ARCH-ARC focused on definitions and end points related to aortic arch–specific anatomy, pathology, and procedures and clinical, device, and imaging. The adoption of the ARCH-ARC consensus definitions and end points will provide a template for consistent adjudication and event reporting and facilitate comparisons of clinical research studies involving devices for ascending aorta and arch pathology.
Article Details
Authors (37)
Adam W. Beck
Department of Surgery and Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham (A.W.B.).
Nimesh D. Desai
Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia (N.D.D.).
Dorothy Abel
Abel and Wolf Consulting, Santa Rosa, CA (D.A.).
Cherrie Z. Abraham
Division of Vascular Surgery, Oregon Health & Science University, Portland (C.Z.A.).
Joseph E. Bavaria
Jefferson Health and the University’s Sidney Kimmel Medical College, Philadelphia, PA (J.E.B.).
Jeffrey N. Browndyke
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC (J.N.B.).
Rachel E. Clough
School of Biomedical Engineering and Imaging Science, King’s College London, St. Thomas’ Hospital, UK (R.E.C.).
Jean-Philippe Collet
Donald E. Cutlip
Department of Medicine, Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D.E.C.).
Martin Czerny
Matthew J. Eagleton
Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston (M.J.E.).
Anthony L. Estrera
Department of Cardiothoracic and Vascular Surgery, McGovern Medical School, University of Texas Health Science Center at Houston and Memorial Hermann Hospital, TX (A.L.E.).
Dominik Fleischmann
Department of Radiology, Stanford University School of Medicine, Palo Alto, CA (D.F.).
Stephan Haulon
Division of Vascular Surgery, Aortic Centre, Hôspital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris-Saclay, France (S.H.).
Robin H. Heijmen
Department of Cardio-Thoracic Surgery, Radboud University Medical Center, Nijmegen, the Netherlands (R.H.H.).
Karen M. Kim
University of Texas Health Austin/Dell Medical School (K.M.K.).
Tilo Kölbel
Department of Vascular Medicine, German Aortic Center, University Medical Center Hamburg-Eppendorf, Hamburg (T.K.).
Mitchell W. Krucoff
Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.).
Alexandra J. Lansky
Department of Internal Medicine, Section of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L.).
Bradley G. Leshnower
Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, GA (B.G.L.).
Sean P. Lyden
Heart Vascular and Thoracic Institute, Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Michael Mack
From Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ (P.G.); Columbia University Medical Center/New York Presbyterian Hospital (A.S., R.T.H., M.B.L.), the Cardiovascular Research Foundation (D.J.C., R.T.H., B.R., M.B.L.), and Weill Cornell Medicine (B.R.), New York, and St. Francis Hospital and Heart Center, Roslyn (D.J.C.) — all in New York; University of Colorado Health, Medical Center of the Rockies, Loveland (J.B.O.); Laval University, Quebec, QC (P.P.), St. Paul’s Hospital, University of British Columbia, Vancouver (P.B., J.L.), and McMaster University, Hamilton, ON (T.S.) — all in Canada; Vanderbilt University Medical Center, Nashville (B.R.L., K.G.); Emory University, Atlanta (V.B.); the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University, Stanford (W.F.F.), VA Palo Alto Health Care System, Palo Alto (W.F.F.), California Pacific Medical Center, San Francisco (D.V.D.), Cedars–Sinai Medical Center, Los Angeles (R.R.M.), and Edwards ...
Tara M. Mastracci
Division of Surgery and Interventional Sciences, University College London, UK (T.M.M.).
Jon S. Matsumura
Roxana Mehran
Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
Germano Melissano
Division of Vascular Surgery, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy (G.M.).
Steven R. Messé
Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (S.R.M.).
Marie-Claude Morice
Department of Cardiology, Cardiovascular Institute Paris-Sud, Hopital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France (M.-C.M.).
Christoph A. Nienaber
Gustavo S. Oderich
Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, TX (G.S.O.).
Kenneth Ouriel
NAMSA, Northwood, OH (K.O.).
Maral Ouzounian
Ourania Preventza
Heart Surgeons of San Antonio, TX (O.P.).
Timothy A. Resch
Department of Vascular Surgery, Copenhagen Aortic Centre, Copenhagen University Hospital, Rigshospitalet, Denmark (T.A.R.).
Eric E. Roselli
Aorta Center, Department of Thoracic and Cardiovascular Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic, OH (E.E.R.).
Ernest Spitzer
Cardialysis, Rotterdam, the Netherlands
Gregory Piazza
Thrombosis Research Group, Brigham and Women’s Hospital, Harvard Medical School, Boston