About The Study

Drug Eluting Stents and Stent Leadership

Challenge: 

In the early days of the Drug-Eluting Stent market, we were turned to by many start-up enterprises to design their IDE DES clinical trials, as a clear pathway for these emerging devices was lacking at the time.

Solution:

As an academic research organization (ARO), we are probably best known for our work in the stent space, which began in the late 1990s. Today, we maintain this focus on stent and trial design in general, by employing novel approaches that consider safety and efficacy as well as real-world applicability.

If one looks at the history of the bare metal stent (BMS) era (beginning with the second generation) and the drug eluting stent (DES) era that immediately followed, our role and impact are highly apparent. The following table provides an overview of our involvement in the development of these breakthrough therapies.

Time Period

Our Role

1996-1998

The Bare Metal Stent Development Era (2G)

  • Designed, coordinated and provided ARO services for the pivotal studies of second-generation BMS
  • Played key role in FDA approval of the great majority of these devices
  • Developed many of the standardized processes for endpoint adjudication and reporting during this era

2000-2010
The Drug Eluting Stent Development Era

  • Designed, coordinated and provided ARO services for the SIRIUS trial, the first randomized trial leading to FDA approval of a DES, the Cypher Stent (Cordis)
  • Provided event adjudication for all TAXUS trials (Boston Scientific)
  • Designed, coordinated and provided ARO services for the program of clinical trials leading to FDA approval of the Endeavor DES and subsequent Resolute DES (Medtronic)
  • Provided event adjudication for most of the SPIRIT clinical trials leading to FDA approval of the everolimus DES (Abbott)
  • Helped lead academic efforts for assessing and developing solutions for the stent thrombosis problem and presentation to FDA
  • Founded the Academic Research Consortium (ARC) leading to standardized classification of stent thrombosis (2006)
  • Designed and ran the DAPT Study (2009-2015) as study sponsor

One of the ways in which Baim Institute was able to shape this area was by working through an entire program with a company, often from First-In-Man, through Feasibility, Pivotal and sometimes beyond, including post-market studies.  This table illustrates the depth of DES experience we possess.

Outcome:

This close engagement with the organization during the product lifecycle enabled our team to possess superb familiarity with the device and its data and at the same time developed a pathway that satisfied the FDA’s requirements.  This working relationship also formed a partnership with these companies that enabled a close working relationship between our respective teams. This resulted in many PMA approvals for device number of companies in this competitive space, beginning with the first of multiple generations of the device. Because of the highly entrepreneurial nature of this industry, many individuals have worked with us on a serial basis – as they move on to new startup ventures they turn again to us to help with their needs as they start to contemplate trial design, FDA interactions and trial operations.