Drug Eluting Stents and Stent Leadership

About The Study

Challenge

In the early days of the Drug-Eluting Stent market, many start-up enterprises turned to Baim 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

1996-1998

The Bare Metal Stent Development Era (2G)

2000-2010
The Drug Eluting Stent Development Era

Our Role

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

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

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 collaboration fostered a partnership with these companies, enabling close cooperation between our teams. This resulted in many PMA approvals for a number of device 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 Baim on a serial basis – as they move on to new startup ventures, they turn again to Baim to help with their needs as they start to contemplate trial design, FDA interactions and trial operations.