4 results
The primary objectives of the trial are to:- Evaluate the efficacy of the PCL-based bulking agent treatment as determined by the Stamey Grading System (SGS). The SGS will be determined at baseline, 3, 6, 12, 18, and 24 months follow-up. - Evaluateā¦
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by a Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery
1. To determine the change in plaque characteristics of non-culprit LRPs, as measured with IVUS/NIRS, after treatment with DEB in patients with ACS.2. To develop a non-invasive algorithm that is able to detect LRPs with CT.
To determine the change in plaque characteristics after treatment with DEB of additional LRPs, as measured by IVUS / NIRS, in ACS patients.