Principal Investigator:
Morris Mosseri, MD

Sponsor
Cardialysis
Monitor

Abstract
The study is designed as a randomized, multicenter, double-blind, clinical trial with 6-months angiographic and IntraVascular Ultrasound (IVUS) follow-up as well as clinical follow-up at 1, 6, and 12 months.
The primary objective of the study is to assess the effect of Intravascular Sonotherapy after de novo stenting in patients with one or more stentable lesions with respect to the in-stent loss at 6 months as assessed by off-line quantitative coronary angiography (QCA). The secondary objective is to compare the different strategies with respect to: 1. major adverse cardiac events at 1,6, and 12 months, 2. restenosis as assessed by QCA at 6 months, 3. neo-intimal hyperplasia and remodeling at 6 months as assessed by IVUS, 4. late thrombotic occlusion after discontinuation of Clopidogrel or Ticlopidine at 1 month and 5. short term and long term safety.
Patients eligible for de novo stenting of one or more lesions with the BXTMVelocityTM stent are included in the study. One or more stented lesions (up to 35 mm stent length), located in a major epicardial vessel or one of its major branches will be treated by active Intravascular Sonotherapy or by sham treatment.
Four hundred patients will be randomized to two groups of two hundred patients.

Status
Waiting for Helsinki approval