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Standardized End Point Definitions for Clinical Trials in Thoracic Aortic Repair: A Consensus Report From the
Adam W Beck1, Nimesh D Desai2, Dorothy Abel3
1Department of Surgery and Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham (A.W.B.).
Circulation
|June 1, 2026
Summary
The Aortic Arch Academic Research Consortium (ARCH-ARC) established standardized definitions and clinical endpoints for novel ascending aorta and arch treatments. This consensus provides a template for consistent research and device comparisons in aortic pathology studies.
Area of Science:
- Cardiovascular Surgery
- Medical Device Research
- Clinical Trials
Background:
- Novel catheter-based and hybrid procedures are advancing the treatment of ascending aorta and arch pathology.
- There is a critical need for standardized strategies to ensure the safe application of these innovative treatments.
Purpose of the Study:
- To establish consistent clinical endpoints and standardize definitions for research on new ascending aorta and arch technologies.
- To develop a consensus-based framework for evaluating novel treatments in this complex anatomical region.
Main Methods:
- The Aortic Arch Academic Research Consortium (ARCH-ARC) convened international specialists from diverse fields including cardiac surgery, vascular medicine, cardiology, neurology, radiology, and clinical trials.
- Virtual meetings were held between 2021 and 2025, involving representatives from regulatory bodies, industry, and contract research organizations.
- Consensus methodologies were employed to define endpoints and standardize terminology for clinical trials involving the ascending aorta and arch.
Main Results:
- Consensus was reached on appropriate clinical endpoints and standardized definitions for endovascular, hybrid, and open surgical procedures.
- The ARCH-ARC focused on definitions and endpoints specific to aortic arch anatomy, pathology, procedures, clinical outcomes, devices, and imaging.
- The developed framework builds upon previous work by the ARC in other clinical areas.
Conclusions:
- The adoption of ARCH-ARC consensus definitions and endpoints will create a template for consistent adjudication and event reporting.
- This standardization will facilitate more robust comparisons across clinical research studies evaluating devices for ascending aorta and arch pathology.
- The ARCH-ARC provides a crucial foundation for advancing the safe and effective treatment of aortic arch diseases.
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