VGS Online Academy

Study design & primary objectives

NCT03209609 (clinicaltrials.gov reference #)

 Trial period: Q1/2018 – Q2/2023

 Sample size: N=224

Participating centers:

15 Centers in the U.S and Canada

Principal investigators:

1. Dr. John Puskas, Mount Sinai, NY
2. Dr. Daniel Goldstein, Montefiore, NY
   
   

Design:
Prospective, multicenter, randomized, self-controlled, open label study to evaluate the safety and effectiveness of VEST in supporting SVGs in CABG surgery.

The study protocol was designed in partnership with the Cardiothoracic Surgical Trials Network (CTSN) to include SVG occlusion in the primary endpoint together with intimal hyperplasia. 

The rationale was to look at SVG failure as a progressive disease in which intimal hyperplasia leads to occlusion (thrombosis and atherosclerosis) and in addition, to prevent a need for further separate studies looking at SVG occlusion.  

The design is similar to VEST I, III and IV trials in which reduction in intimal hyperplasia was the primary endpoint.
CTSN’s objective was that positive results from this trial will be directly translated into guidelines and lead to wide adoption with no need for further trials.

5Y follow up with primary endpoint for IDE submission at 1Y.
 

Primary Endpoint:
Intimal hyperplasia area (plaque + media) as assessed by IVUS + SVG occlusion at 12M post-index CABG