Clinical Trial: Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds

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).


Detailed Summary:
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Minimal in-scaffold lumen area (mm2) as assessed by OCT [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of adverse events [ Time Frame: 6 months ]
    Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT)
  • OCT imaging endpoints [ Time Frame: 6 months ]
    Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT)
  • Additional OCT imaging endpoints [ Time Frame: 6 months ]
    • Significant malapposed scaffold struts, %
    • Malapposed scaffold struts, %
    • Uncovered scaffold struts, %
    • Incomplete scaffold apposition area, mm2
    • Incomplete scaffold apposition distance, mm
    • Neointimal thickness, µm
    • Neointimal area, mm2
    • Volume obstruction, %
  • OCT imaging endpoints [ Time Frame: end of procedure ]
    • Minimal in-scaffold lumen area, mm
    • Scaffold expansion, %
    • No of patients with scaffold expansion <80%
    • % lesions with significant malapposition
    • % malapposed struts
  • angiographic endpoints [ Time Frame: end of procedure ]
    • acute lumen gain
    • in-scaffold minimal lumen diameter
    • in-segment minimal lumen diameter
    • in-scaffold % diameter stenosis
    • in-segment % diameter stenosis
  • angiographic endpoints [ Time Frame: 6 months ]
    • In-scaffold late lumen loss, mm
    • In-segment late lumen loss, mm
    • In-scaffold % diameter stenosis
    • In-segment % diameter stenosis
    • Binary restenosis, %
    • Percent diameter stenosis, %


Original Secondary Outcome: Number of adverse events [ Time Frame: 6 months ]

Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT)


Information By: University Hospital Inselspital, Berne

Dates:
Date Received: January 22, 2016
Date Started: March 2016
Date Completion: March 2021
Last Updated: September 6, 2016
Last Verified: September 2016