Study Design
BEST-CLI is a prospective, multicenter, randomized, open label (two-arm), comparison trial to evaluate the effectiveness of best surgical (OPEN) compared to best endovascular (EVT) revascularization in patients with CLI.
2100 subjects will be recruited from approximately 130 multidisciplinary vascular centers and practices in the US and Canada. BEST-CLI is funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Given that a variety of specialists treat CLI, a Specialty Principal Investigator (PI) is appointed, at every site, for each specialty that treats CLI and is participating in the trial.
These specialties include:
Interventional Cardiology
Interventional Radiology
Vascular Medicine
Vascular Surgery
The BEST-CLI Trial is a multidisciplinary trial and to that end has defined a mandate to engage all physicians who treat CLI at any given site to the extent possible. Interdisciplinary collaboration is essential to the success of the trial and will take place within the construct of a CLI Team as described below.
The NHLBI in funding this trial clearly delineated their intention that all stakeholders who manage patients with CLI be engaged and included in the Trial. As such, Investigators who are part of BEST-CLI Trial will be expected to communicate and interact with one another, across and within participating specialties, in such a way as to facilitate enrollment of subjects into the trial. Furthermore, both in the interest of optimizing subject care and to ensure balanced comparison between study cohorts, optimal surgical and endovascular treatment should be provided by those with greatest skill and experience. This implies that, at each site, there are operators who are knowledgeable, broadly trained in the evaluation and management of patients with CLI, highly skilled, experienced, and in the aggregate, capable of performing the therapy to which each subject is randomly assigned. Implicit in this expectation is a demonstrated commitment to the longitudinal care of subjects with CLI pre- and post-revascularization, inclusive of outcome assessment and ongoing surveillance in an effort to optimize long term results.
The CLI Team is defined as a group of individuals at a given site who are treating subjects with CLI within the confines of the BEST-CLI Trial and any associated ancillary study or registry. It consists of Specialty PIs (including the Contact PI), Co-Is, and Clinical Research Coordinators. Its mission is to maximize inter-specialty collaboration within each site to ensure successful conduct of the BEST-CLI Trial.
The goals of the CLI Team are:
To ensure enrollment of subjects into the Trial, through open communication among participating specialists.
To create and support an environment at every Trial site that is conducive to physician collaboration and subject recruitment.
To deliver the optimal open surgical or endovascular treatment and to ensure standard of care treatment within the strategy to which each subject is randomized in the Trial.
To foster constructive collegiality, information exchange and education amongst Investigators and optimal communication of the Trial aims and mission throughout the local medical community.
To ensure that best medical therapy and vascular risk factor management is practiced.