Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16 because a lesion was identified in the left femoral-popliteal artery. The lesion was deemed severe and extensive and the subject was not a good candidate for angioplasty (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with Prior Intervention to show that this is not the study procedure.
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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
Peripheral Artery Bypass Graft
Prior Intervention
1
SCREEN
2007-01-01
2005-12-16T06:00
2005-12-16T09:00
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The findings about procedure dataset below shows several important parameters from the Prior Peripheral Artery Bypass Surgery:
The native vessel on which the bypass graft was built - row 1.
The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
The locations where the two ends of the bypass vessel graft connect with the native vessel - rows 3-4.
These records were originally represented as SUPPTU (in IG3.4 and the CV TAUG), but I think they are better fitted for FAPR? Thoughts?
Row 1:
Shows the graft vessel was built on the Left Femoral-popliteal Artery.
Row 2:
Shows the bypass graft type was venous cadaveric graft, which is composed of a vein harvested from a cadaver.
Rows 3-4:
Show the graft anastomoses (connections) to the Left Femoral-popliteal Artery were on the Left Common femoral Artery and Left Popliteal Artery.
fa.xpt
fapr.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATEST
FAOBJ
FACAT
FAORRES
VISITNUM
VISIT
TUDTC
1
TUDY01
FA
40912
1
Graft Vessel Construction Location
Peripheral Artery Bypass Graft
Prior Intervention
Left Femoral-popliteal Artery
1
SCREEN
2007-01-01
2
TUDY01
FA
40912
2
Bypass Graft Type
Peripheral Artery Bypass Graft
Prior Intervention
Cardaveric Graft, Venous
1
SCREEN
2007-01-01
3
TUDY01
FA
40912
3
Graft Anastomosis (connection) Location
Peripheral Artery Bypass Graft
Prior Intervention
Left Common femoral Artery
1
SCREEN
2007-01-01
4
TUDY01
FA
40912
4
Graft Anastomosis (connection) Location
Peripheral Artery Bypass Graft
Prior Intervention
Left Popliteal Artery
1
SCREEN
2007-01-01
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
On 2007-01-05, at an unscheduled visit, the subject had undergone cardiac catheterization during which time two separate lesions were located in the left leg of the subject. One lesion (lesion 1) was in the native left femoral-popliteal artery (this was the lesion that led to the graft bypass surgery back in 2005) the other lesion (lesion 2) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, lesion 2 is considered as target for PVI - a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (Lesion 2). PRDTC (the date of collection) was populated with the start date/time of the procedure.
Below procedure data show cardiac catheterization and stent implantation.
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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
Cardiac Catheterization
Diagnostic
1.1
UNSCHEDULED
2007-01-05
2007-01-05T07:00
2007-01-05T10:00
2
TUDY01
PR
40912
1
Stent Implantation
PVI
1.1
UNSCHEDULED
2007-01-05
2007-01-05T07:00
2007-01-05T10:00
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The below data show Locations and Roles of the identified lesions.
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
Shows the limb that contains lesion is the left leg.
Row 3:
Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 4:
Shows the lesion is found in the left popliteal artery, in the segment above the knee.
Row 5:
Shows the major vessel that contains a lesion is the femoro-popliteal graft.
Row 6:
Shows the lesion is located in the proximal anastomosis (connection) of the femoro-popliteal graft. (Note I created two rows here, depending on how you ask the question, whether "graft" is pre-coordinated into TUTEST, TULOC value will change).
Row 7:
Shows the affected left femoro-popliteal peripheral artery is considered as non-target. In the context of clinical investigation, non-target is any vessel or bypass graft not treated or for which treatment was not attempted with a device or technique being studied. This includes vessels treated with (nonstudy) vascular intervention and vessels managed medically. (ACC/AHA Clinical Data Standards 2014)
Row 8:
Shows the lesion is considered as non-target. In the context of clinical investigation, any lesion not treated or for which treatment was not attempted with the device or technique being studied. This includes lesions treated with (nonstudy) PVI and lesions managed medically. (ACC/AHA Clinical Data Standards 2014)
Row 9:
Shows the affected femoro-popliteal graft vessel is considered as target. In the context of clinical investigation, a target vessel is a blood vessel that contains the target lesion and treated with the study device. (ACC/AHA Clinical Data Standards 2014)
Row 10:
Shows the lesion in the femoro-popliteal graft vessel is considered as target. In the context of clinical investigation, any lesion treated or for which treatment was attempted with a device or technique being studied. (ACC/AHA Clinical Data Standards 2014)
Row 11:
Shows the left leg is considered as target.
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tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTEST
TULOC
TULAT
TULOCDTL
TUORRES
TUSTRESC
TU Result LOC
TU Result LAT
TU Result LOCDTL
TUMETHOD
TUEVEL
VISITNUM
VISIT
TUDTC
1
TUDY01
TU
40912
1
Lesion Indicator
LOWER LIMB REGION
Y
Y
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
2
TUDY01
TU
40912
2
Limb 1
Limb with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEG
LEFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
3
TUDY01
TU
40912
3
Vessel 1-Lesion 1
Vessel with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
4
TUDY01
TU
40912
4
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
POPLITEAL ARTERY
LEFT
ABOVE KNEE
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
5
TUDY01
TU
40912
5
Graft Vessel 1-Lesion 2
Vessel with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEFT FEMORO-POPLITEAL GRAFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
6
TUDY01
TU
40912
6
Lesion 2
Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEFT FEMORO-POPLITEAL GRAFT
ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
6
TUDY01
TU
40912
6
Lesion 2
Graft Lesion Location Identification
LEFT FEMORO-POPLITEAL GRAFT
LOCATED
LOCATED
GRAFT ANASTOMOSIS PROXIMAL
5MM FROM THE ORIGIN OF THE GRAFT
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
7
TUDY01
TU
40912
8
Vessel 1-Lesion 1
Vessel with Lesion Role Identification
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
NON-TARGET
NON-TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
8
TUDY01
TU
40912
9
Lesion 1
Lesion Role Identification
POPLITEAL ARTERY
LEFT
ABOVE KNEE
NON-TARGET
NON-TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
9
TU
40912
10
Graft Vessel 1-Lesion 2
Vessel with Lesion Role Identification
LEFT FEMORO-POPLITEAL GRAFT
LEFT
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
10
TUDY01
TU
40912
11
Lesion 2
Lesion Role Identification
LEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMAL
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
11
TUDY01
TU
40912
12
Limb 1
Limb with Lesion Role Identification
LEG
LEFT
TARGET
TARGET
PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
1.1
UNSCHEDULED
2007-01-05
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Note the following parameters have been mapped to TR in the published CV-endpoint TAUG, but I wonder if they are actually "disease response to treatment" type of data. Whether the target lesion or the target affected major vessel have failed (or using tumor RS terminology, did not responded to) percutaneous vascular intervention treatment has very specific definition by published criteria.
Row 1:
The target lesion in the graft did not fail according to XXXX.
Row 2:
The target graft vessel did not fail according to XXX.
Row 3:
The target graft vessel is patent according to XXX.
Row 4:
The target limb did not fail according to XXXX.
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRLNKID
TRTEST
TRORRES
TRSTRESC
TRMETHOD
VISITNUM
VISIT
CVDTC
1
TUDY01
TR
40912
1
TARGET
Lesion 2
Lesion Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
1.1
UNSCHEDULED
2007-01-05
3
TUDY01
TR
40912
3
TARGET
Graft Vessel 1-Lesion 2
Vessel Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
1.1
UNSCHEDULED
2007-01-05
4
TUDY01
TR
40912
4
TARGET
Graft Vessel 1-Lesion 2
Vessel Patency Indicator
Y
Y
PERIPHERAL ANGIOGRAPHY
1.1
UNSCHEDULED
2007-01-05
5
TUDY01
TR
40912
5
TARGET
Limb 1
Limb Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
1.1
UNSCHEDULED
2007-01-05
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.
Row 1:
The target lesion in the graft did not fail treatment according to ACC/AHA Clinical Data Standards 2014.
Row 2:
The target graft vessel did not fail treatment according to ACC/AHA Clinical Data Standards 2014.
Row 3:
The target graft vessel is patent according to ACC/AHA Clinical Data Standards 2014.
Row 4:
The target limb did not fail treatment according to ACC/AHA Clinical Data Standards 2014.
