Bifurcation ABSORB OCT Trial

Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts

3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.

Time frame: Baseline

Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B

3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.

Time frame: 24 months

Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C

3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.

Time frame: 36 months

Incomplete strut apposition in the bifurcation region - All cohorts

Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: Baseline

Incomplete strut apposition in the bifurcation region - Cohort A

Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 12 months

Incomplete strut apposition in the bifurcation region - Cohort B

Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 24 months

Incomplete strut apposition in the bifurcation region - Cohort C

Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 36 months

Number of embedded and protruded ABSORB BVS struts per region - All cohorts

Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.

Time frame: Baseline

Number of embedded and protruded ABSORB BVS struts per region - Cohort A

Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.

Time frame: 12 months

Number of embedded and protruded ABSORB BVS struts per region - Cohort B

Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.

Time frame: 24 months

Number of embedded and protruded ABSORB BVS struts per region - Cohort C

Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.

Time frame: 36 months

Incomplete strut coverage in the bifurcation region - Cohort A

Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 12 months

Incomplete strut coverage in the bifurcation region - Cohort B

Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 24 months

Incomplete strut coverage in the bifurcation region - Cohort C

Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.

Time frame: 36 months

The number of non-apposed side branch (NASB) struts - All cohorts

Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.

Time frame: Baseline

The number of non-apposed side branch (NASB) struts - Cohort A

Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.

Time frame: 12 months

The number of non-apposed side branch (NASB) struts - Cohort B

Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.

Time frame: 24 months

The number of non-apposed side branch (NASB) struts - Cohort C

Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.

Time frame: 36 months

Tissue in-between non-apposed side branch (NASB) struts - Cohort A

Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.

Time frame: 12 months

Tissue in-between non-apposed side branch (NASB) struts - Cohort B

Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.

Time frame: 24 months

Tissue in-between non-apposed side branch (NASB) struts - Cohort C

Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.

Time frame: 36 months

Mean/Minimal Lumen diameter/area - All cohorts

Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area

Time frame: Baseline

Mean/Minimal Lumen diameter/area - Cohort A

Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area

Time frame: 12 months

Mean/Minimal Lumen diameter/area - Cohort B

Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area

Time frame: 24 months

Mean/Minimal Lumen diameter/area - Cohort C

Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area

Time frame: 36 months

Mean/Minimal Scaffold diameter/area - All cohorts

Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.

Time frame: Baseline

Mean/Minimal Scaffold diameter/area - Cohort A

Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.

Time frame: 12 months

Mean/Minimal Scaffold diameter/area - Cohort B

Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.

Time frame: 24 months

Mean/Minimal Scaffold diameter/area - Cohort C

Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.

Time frame: 36 months

Neointima thickness - Cohort A

Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

Time frame: 12 months

Neointima thickness - Cohort B

Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

Time frame: 24 months

Neointima thickness - Cohort C

Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

Time frame: 36 months

Scaffold pattern irregularities - All cohorts

Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.

Time frame: Baseline

Scaffold pattern irregularities - Cohort A

Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.

Time frame: 12 months

Scaffold pattern irregularities - Cohort B

Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.

Time frame: 24 months

Scaffold pattern irregularities - Cohort C

Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.

Time frame: 36 months