Amsterdam Investigator-initiated Absorb trial the bifurcation strategy

Amsterdam Investigator-initiated Absorb trial the bifurcation strategy - AIDA bifurcation strategy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41341

Enrollment

Registered

2014-07-30

Start date

2014-10-23

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Coronary Artery Disease Coronary Atherosclerosis

Interventions

Intervention of interest is either fenestration or no fenestration of the stent towards the sidebranch.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Subject is enrolled in the Amsterdam Investigator-InitiateD Absorb strategy trial o Subject has a bifurcation lesion involving a side-branch greater than 2 mm (excluding Medina class 0,0,1 where the is no main-branch involvement) o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography o Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion criteria

Exclusion criteria: o Subject is younger than 18 years of age o Subject is presenting with a STEMI o Subject has known hypersensitivity or contraindication to contrast that cannot be adequately pre-medicated. o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) 2.5mg/dL or subject on dialysis) o Subject is belonging to a vulnerable population (per investigator*s judgment, e.g., subordinate hospital staff) or subject unable to read or write.

Design outcomes

Primary

Measure	Time frame
o Incomplete strut apposition in the bifurcation region at 25 months	—

Secondary

Measure	Time frame
OCT endpoints o Incomplete strut apposition in the bifurcation region at baseline o Number of embedded and protruded struts per region at baseline and 25 months o Incomplete strut coverage in the bifurcation region at 25 months o Number of jailed side branch struts (2D-OCT) at baseline and at 25 months o Tissue in-between non-apposed side branch struts at 25 months o Number of jailed side branch struts (3D-OCT) at baseline and at 25 months; V, T, H, double V, double T, and double H. o Mean/Minimal Lumen diameter/area at baseline and 25 months o Mean/Minimal Stent/Scaffold diameter/area at baseline and 25 months o Neointima thickness in the bifurcation region at 25 months o Scaffold pattern irregularities at baseline and 25 months Angiographic endpoints o In-segment Late Loss (LL) postnitrate at 25 months o Proximal LL postnitrate at 25 months o Distal LL postnitrate at 25 months o In-scaffold/in-stent, in-segment, proximal and distal MLD postnitrate at baseline and at 25 months o In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate at baseline and at 25 months o Proximal 5mm SB% diameter stenosis (DS) postnitrate at baseline and at 25 months o In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate at 25 months	—

Measure

Time frame

OCT endpoints o Incomplete strut apposition in the bifurcation region at baseline o Number of embedded and protruded struts per region at baseline and 25 months o Incomplete strut coverage in the bifurcation region at 25 months o Number of jailed side branch struts (2D-OCT) at baseline and at 25 months o Tissue in-between non-apposed side branch struts at 25 months o Number of jailed side branch struts (3D-OCT) at baseline and at 25 months; V, T, H, double V, double T, and double H. o Mean/Minimal Lumen diameter/area at baseline and 25 months o Mean/Minimal Stent/Scaffold diameter/area at baseline and 25 months o Neointima thickness in the bifurcation region at 25 months o Scaffold pattern irregularities at baseline and 25 months Angiographic endpoints o In-segment Late Loss (LL) postnitrate at 25 months o Proximal LL postnitrate at 25 months o Distal LL postnitrate at 25 months o In-scaffold/in-stent, in-segment, proximal and distal MLD postnitrate at baseline and at 25 months o In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate at baseline and at 25 months o Proximal 5mm SB% diameter stenosis (DS) postnitrate at baseline and at 25 months o In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate at 25 months

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)