Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16.
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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
CORONARY ARTERY BYPASS GRAFT
PRIOR SURGERY
1
SCREEN
2007-01-01
2005-12-16T06:00
2005-12-16T09:00
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Row 1:
Shows the graft vessel was built on the LEFT FEMORO-POPLITEAL ARTERY.
Row 2:
Shows the bypass graft type was venous cadaveric graft, which is composed of a artery harvested from a cadaver.
Rows 3-4:
Show the graft anastomoses (connections) to the LEFT FEMORO-POPLITEAL ARTERY were on the LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY.
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fapr.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATEST
FAOBJ
FACAT
FAORRES
VISITNUM
VISIT
TUDTC
1
TUDY01
FA
40912
1
Graft Construction Location
CORONARY ARTERY BYPASS GRAFT
PRIOR SURGERY
LEFT FEMORO-POPLITEAL ARTERY
1
SCREEN
2007-01-01
2
TUDY01
FA
40912
2
Bypass Graft Type
CORONARY ARTERY BYPASS GRAFT
PRIOR SURGERY
CADAVERIC GRAFT, VENOUS
1
SCREEN
2007-01-01
3
TUDY01
FA
40912
3
Graft Anastomosis (connection) Location
CORONARY ARTERY BYPASS GRAFT
PRIOR SURGERY
LEFT COMMON FEMORAL ARTERY
1
SCREEN
2007-01-01
4
TUDY01
FA
40912
4
Graft Anastomosis (connection) Location
CORONARY ARTERY BYPASS GRAFT
PRIOR SURGERY
LEFT POPLITEAL ARTERY
1
SCREEN
2007-01-01
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
Two lesions are located
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
shows the native vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 3:
Shows the lesion is found in the left popliteal artery above the knee.
Row 4:
Shows the graft vessel that contains a lesion is the femoro-popliteal graft.
Row 5:
Shows the lesion is located in the proximal anastomosis (connection) of the graft.
Row 6:
Shows the limb that contains lesion is the left leg.
Row 7:
Shows the lesion in the native vessel is considered as non-target. In the context of clinical investigation, 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 graft vessel is considered as target. In the context of clinical investigation, a target vessel is any noncardiac or nonintracranial blood vessel that contains the target lesion treated with the study device.
Row 10:
Shows the lesion in the graft vessel is considered 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. The target limb is the extremity that contains the target lesion and all the native vessels upstream and downstream from it, including side branches.
(Jordan: this data element is really terrible, because a graft lesion can be a target lesion if deemed treatable by PVI, so the limb that contains a graft lesion would also be considered as a target limb. I hate common data elements, i think this test should just be removed from the dataset because the original source is really terrible.)
Row Captions Debug Message
Please capitalize the first letter of each row caption.
Note these parameters have been mapped to TR in the published CV-endpoint TAUG, but i think they are "disease response to treatment" type of data. Whether the lesion or the affected 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.
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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
2
BASELINE
2007-02-01
3
TUDY01
TR
40912
3
TARGET
Graft Vessel 1-Lesion 2
Vessel Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
4
TUDY01
TR
40912
4
TARGET
Graft Vessel 1-Lesion 2
Vessel Patency Indicator
Y
Y
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
5
TUDY01
TR
40912
5
TARGET
Limb 1-Lesion 2
Limb Failure Indicator
N
N
PERIPHERAL ANGIOGRAPHY
2
BASELINE
2007-02-01
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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 PVI treatment according to ACC/AHA Clinical Data Standards 2014.
Row 2:
The target graft vessel did not fail PVI 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 PVI treatment according to ACC/AHA Clinical Data Standards 2014.