Dutch BifUrcaTion Study Evaluating CHaracteristics of the Side Branch Opening with Optical Coherence Tomography after Side Branch FENestration in Patients Treated with COMBO or Xience Stent.

Dutch BifUrcaTion Study Evaluating CHaracteristics of the Side Branch Opening with Optical Coherence Tomography after Side Branch FENestration in Patients Treated with COMBO or Xience Stent. - DUTCH OPEN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48918

Enrollment

Registered

2019-11-08

Start date

2020-01-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bifurcation lesion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement, which needs percutaneous coronary intervention with stenting.

Exclusion criteria

Exclusion criteria: Patients with a bifurcation lesie which needs a two stent strategy

Design outcomes

Primary

Measure	Time frame
OCT endpoints o Appearance of overhanging struts in front of the side branch ostium on three-dimensional OCT post-implantation and post-procedure measured by cute-plane analysis o Number of non-apposed side branch (NASB) struts post-implantation and post-procedure o Incomplete strut apposition in the bifurcation region post-procedure o Mean/Minimal Stent diameter/area post-procedure o Mean/Minimal Lumen diameter/area at baseline o Stent pattern irregularities post-procedure Angiographic endpoints o Acute gain of proximal main branch (MB), distal MB and side branch (SB) o In-stent, in-segment, % diameter stenosis proximal and distal MB and SB post-nitrate pre-procedural o Reference vessel diameter of MB o In-stent, in-segment Dmax (maximum diameter) proximal and distal MB and distal SB pre-procedural 3D angiographic endpoints o The bifurcation angle o Minimal lumen area (MLA, in mm2) o Percentage area stenosis (%)	—

Measure

Time frame

OCT endpoints o Appearance of overhanging struts in front of the side branch ostium on three-dimensional OCT post-implantation and post-procedure measured by cute-plane analysis o Number of non-apposed side branch (NASB) struts post-implantation and post-procedure o Incomplete strut apposition in the bifurcation region post-procedure o Mean/Minimal Stent diameter/area post-procedure o Mean/Minimal Lumen diameter/area at baseline o Stent pattern irregularities post-procedure Angiographic endpoints o Acute gain of proximal main branch (MB), distal MB and side branch (SB) o In-stent, in-segment, % diameter stenosis proximal and distal MB and SB post-nitrate pre-procedural o Reference vessel diameter of MB o In-stent, in-segment Dmax (maximum diameter) proximal and distal MB and distal SB pre-procedural 3D angiographic endpoints o The bifurcation angle o Minimal lumen area (MLA, in mm2) o Percentage area stenosis (%)

—

Secondary

Measure	Time frame
Cardiac death myocardial infarction revascularization	—

Countries

Netherlands

Outcome results