Abstract
Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360® Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials.
Original language | English |
---|---|
Pages (from-to) | 378-379 |
Number of pages | 2 |
Journal | Catheterization and Cardiovascular Interventions |
Volume | 88 |
Issue number | 3 |
DOIs | |
Publication status | Published - 1 Sep 2016 |
Externally published | Yes |