Angiographic Core Laboratory

The Angiographic Core Laboratory (ACL), supervised by Alexandra Lansky, MD, provides independent quantitative and qualitative assessment of coronary, peripheral, neurovascular, and venous angiograms using validated endpoints. ACL analysis provides unparalleled consistency and detail in the assessment of procedural and long-term success of devices and interventions, diagnostic validation, and anatomic definition in a broad range of clinical scenarios in the service of single- and multi-center national and international clinical trials. The ACL operates in compliance with Good Clinical Practices (GCP).

In addition to Dr. Lansky, the ACL is led by Ecaterina Cristea, MD. She has more than 20 years of experience in angiographic analysis for clinical trails. Together, ACL staff have performed angiographic analysis for more than 500 clinical trials in a wide variety of therapeutic areas.

The ACL currently performs core laboratory analysis for more than 14 ongoing clinical trials investigating a broad range of novel devices, techniques, and adjunctive pharmacology for the treatment of coronary, carotid, and peripheral artery disease and venous disease. The ACL also has extensive experience with angiographic validation of novel imaging and laboratory tests for the diagnosis and assessment of vascular disease, and in the development and validation of novel surrogate measures of device efficacy.

ACL assessments include qualitative and quantitative measures of:

• Extent and burden of coronary and peripheral artery disease,
  
• Lesion complexity and morphology,
  
• Epicardial and myocardial flow,
  
• Pre- and post-procedural morphology,
  
• Vascular complications, and
  
• Revascularization appropriateness and completeness

ACL methodology is based on the analysis of more than 500,000 angiograms during Lansky's 20-year experience leading an angiographic core laboratory. All measures have been developed and validated using standardized methods.

Case report form and analysis design are customized per protocol for accurate and reproducible analysis, including programming validation and built-in crosschecks. The ACL provides site-training services to optimize data quality and standardization. The reproducibility of all morphologic and quantitative assessments is routinely tested, and the ACL conducts 100% quality control and over-reading.

The ACL is equipped with four dedicated angiographic workstations. Analysis is performed using the latest Quantitative Coronary Analysis (QCA) software, including the latest FDA-cleared versions of the Coronary Measurement System (CMS, MEDIS system, Leiden, The Netherlands) and the Cardiovascular Angiography Analysis System (CAAS, Pie Medical B.V., Maastricht, the Netherlands). The ACL has participated in the design and development of this software to establish standards of quantification and tailor QCA algorithms for specific indications, including stents and drug-eluting stents, vulnerable plaque analysis, bifurcation lesion analysis, and peripheral interventions.

All ACL data is fully integrated into the Yale ITS system with extensive backup, security control, and data recovery implementation. The ACL has passed numerous vendor-initiated audits.