Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Brief Summary:
Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS.
The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as indicated by OCT).