Overview
The Cleveland Clinic Vascular Core Laboratory integrates advanced clinical, research and imaging expertise in vascular surgery with extensive experience in the design and management of clinical trials. As a component of Cleveland Clinic’s Heart, Vascular & Thoracic Institute, the Vascular Core Laboratory supports industry partners, academic institutions and contract research organizations in the execution of rigorous and efficient clinical investigations, including complex multicenter trials.
Core Laboratory Imaging Analysis
Imaging Analysis Services
The Vascular Core Laboratory is directed by Sean P. Lyden, MD, Chair of the Department of Vascular Surgery, in conjunction with Paul D. Bishop, PhD, RVT. The laboratory is staffed by experienced physicians and technical specialists who provide independent and objective imaging analysis across a comprehensive array of modalities, including computed tomography angiography, magnetic resonance imaging and angiography, digital subtraction angiography, ultrasonography and plain radiography. With more than 30 years of experience, the laboratory has established expertise in supporting clinical trials involving aortic, cerebrovascular and peripheral vascular disease.
The Vascular Core Laboratory offers a comprehensive suite of services, including centralized image tracking, oversight of protocol adherence and secure electronic image acquisition from participating sites worldwide. Additional capabilities include the development of study-specific imaging definitions and analytic criteria, application of advanced three- and four-dimensional imaging techniques, rapid adjudication of anatomic eligibility for study enrollment, and the provision of customized imaging analyses aligned with defined trial endpoints.
Partner organizations derive significant benefit from engagement with our Vascular Core Laboratory, including reduction in interobserver variability, assurance of imaging protocol compliance, validation of anatomic inclusion and exclusion criteria, and facilitation of secure image transmission and data management. The laboratory further provides robust quality assurance processes, direct integration of validated results into sponsor databases and timely notification of clinically significant findings. Importantly, laboratory operations remain independent from clinical trial site activities, thereby preserving objectivity and scientific rigor.
Specific Image Analysis Capabilities
The Vascular Core Laboratory performs a broad spectrum of advanced imaging analyses, including:
- Detailed assessment of vessel geometry (diameter, length and angulation)
- Evaluation of imaging protocol compliance
- Analysis of device-related outcomes such as migration, component separation and stent integrity
- Quantitative and longitudinal analysis of aneurysm morphology and growth
- Endoleak detection and assessment of aneurysm exclusion
- Characterization of arterial dissections (including lumen patency and perfusion)
- Evaluation of stenosis and occlusive disease
The laboratory also provides comprehensive assessment of distal runoff and tissue perfusion, quantification of plaque burden and calcification, analysis of vessel tortuosity and dynamic four-dimensional evaluation of biomechanical changes associated with cardiac and respiratory motion.
Services
Research and Development Support
The Vascular Core Laboratory offers substantial support for research and device development through the generation of highly accurate, patient-specific anatomic models derived from advanced imaging datasets, including computed tomography and magnetic resonance imaging. These datasets are processed in accordance with predefined anatomic and disease-specific criteria and converted into standardized digital formats, such as stereolithography (STL) files, compatible with engineering and computational modeling platforms.
Capabilities extend from the generation of precise digital reconstructions to three-dimensional printing and four-dimensional biomechanical characterization. Applications encompass a wide range of biological structures, including arterial and venous systems, cardiac anatomy, musculoskeletal structures, integumentary surfaces, solid organs, respiratory anatomy and central nervous system structures.
Specific offerings include:
- Ability to model any anatomical structure needed (cardiovascular, orthopaedic, etc.)
- Accurate 3D anatomic geometry surfaces and volumes
- Biomechanical 4D characterization
- Generation of digital files from medical imaging (CT/MRI)
- Ability to model normal, diseased and device-implanted anatomy
- Digital files to support engineering, computer modeling and 3D printing
- 3D printing
Clinical Trial Data Management
Experienced, knowledgeable data management experts provide the following high-quality services:
- Case report form development
- 21 CFR 11–compliant database design
- Development of data management plans
- Data tracking
- Data edit checks/validation
- Discrepancy resolution
- Data extraction, lock and transfers
Trials are managed from startup to closeout by following GCP and ICH Guidelines.
Project and Site Management
Our staff has extensive clinical and research expertise to assist with cost-effective and efficient study design and site management services. You will be assigned a designated project manager as your primary contact. Each site will be assigned a site manager for individualized communication, identification and resolution of study-related questions and issues in a timely manner. Services include:
- Informed consent template development
- Protocol and case report form development
- Site selection and site management
- Study team training
- Development of educational tools for use by site study team
- Assistance with IRB and/or other regulatory issues
- Study investigator and/or coordinator meeting planning and execution
- Site study team training or hosting informational webcasts
CEC, DSMB, and Executive and Steering Committees
We can assist in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees and Steering Committees, including creation of the charters/guidelines to operationalize these committees. We also can provide Clinical Events Committee (CEC) services with an independent blinded analysis to determine trial endpoints and events.
Statistics
Our staff has extensive clinical and research expertise to assist with the analysis of clinical trial data to help support summary activities ranging from regulatory reporting to manuscript preparation. Services include:
- Protocol design and review
- Sample size determination
- Statistical analysis planning
- Independent validation of results
- Statistical support for manuscripts
Graphics and Design
Our on-site graphics team can add that professional touch to your trial materials. Our talented degreed professionals can assist with guides, training materials, figures for manuscripts or podium presentations, newsletters, brochures and any other digital/print items needed.
Contact Us
Contact Information
For further information regarding the capabilities of the Vascular Core Laboratory or potential collaborations, please contact:
Paul D. Bishop, PhD, RVT
Director, Vascular Core Laboratory
Email: bishopp@ccf.org
Telephone: 216.312.9449
Faculty
The Vascular Core Laboratory is supported by a multidisciplinary faculty comprising nationally and internationally recognized leaders in vascular and cardiac surgery and related disciplines. Participating physicians include: Ravi Ambani, MD; Francis Caputo, MD; Gayan De Silva, MD; Ali Khalifeh, MD; Roy Miler, MD; Jon Quatromoni, MD; Anthony Rizzo, MD; Sean Steenberge, MD; and Eric Roselli, MD.
Neurovascular collaborations are supported by Shazam Hussain, MD; Michal Obrzut, MD; Peter Rasmussen, MD; and Jenny Tsai, MD.
