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 percutaneous vascular intervention (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with Prior Intervention. This information is collected during the SCREEN visit on 2007-01-01 (PRDTC).
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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRLOC
PRLAT
PRCAT
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
Peripheral Artery Bypass Graft
Femoral-popliteal Artery
Left
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
2
TUDY01
FA
40912
2
Bypass Graft Type
Peripheral Artery Bypass Graft
Prior Intervention
Cadaveric Graft, Venous
1
SCREEN
2007-01-01
3
TUDY01
FA
40912
3
Proximal Graft Anastomosis (connection) Location
Peripheral Artery Bypass Graft
Prior Intervention
Common femoral Artery
1
SCREEN
2007-01-01
4
TUDY01
FA
40912
4
Distal Graft Anastomosis (connection) Location
Peripheral Artery Bypass Graft
Prior Intervention
Popliteal Artery
1
SCREEN
2007-01-01
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
On 2007-01-03, the subject had undergone lower-extremity CT peripheral angiography 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 (graft lesion 1) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, graft lesion 1 is considered as target for the subsequent PVI treatment. On 2007-01-05, a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.
Below procedure data show cardiac catheterization and stent implantation.
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pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRTRT
PRCAT
PRLOC
VISITNUM
VISIT
PRDTC
PRSTDTC
PRENDTC
1
TUDY01
PR
40912
1
CT PERIPHERAL ANGIOGRAPHY
DIAGNOSTIC
LOWER EXTREMITIES
2
VISIT 1
2007-02-07
2007-01-03T08:00
2007-01-03T09:00
TUDY01
PR
40912
2
CT PERIPHERAL ANGIOGRAPHY
PVI
2
VISIT 1
2007-02-07
2007-01-05T07:00
2007-01-05T09:00
2
TUDY01
PR
40912
3
Cardiac Catheterization
PVI
2
VISIT 1
2007-02-07
2007-01-05T07:00
2007-01-05T09:00
3
TUDY01
PR
40912
4
Stent Implantation
PVI
2
VISIT 1
2007-02-07
2007-01-05T07:00
2007-01-05T09:00
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Lesion Location Identification
The below data show Locations of the lesions.
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
Shows the location of the lesion in the native vessel.
Row 3:
Shows the location of the lesion is in the FEMORO-POPLITEAL ARTERY graft. Note the use of the NSV --RLGFFG, Result location is graft flag. Note i did map PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT to TU result LOCDTL because this variable is not controlled and the flag indicates that we are dealing with a graft location.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTEST
TULOC
TUORRES
TUSTRESC
TU Result LOC
TU Result LAT
TU Result LOCDTL
TUMETHOD
TUEVEL
VISITNUM
VISIT
TUDTC
TURLGFFG
1
TUDY01
TU
40912
1
Lesion Indicator
LOWER LIMB REGION
Y
Y
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
2
TUDY01
TU
40912
2
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
POPLITEAL ARTERY
LEFT
ABOVE KNEE
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Graft Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
FEMORO-POPLITEAL ARTERY
LEFT
PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
Y
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.
Question: Can we use LOC for Graft locations? LOC in most findings domains is supposed to be the location where a test is performed, and RESLOC is where a result is collected. SDTM does not specify that the location needs to be a "naturally occurring" body part, so can we get away with mapping graft locations into LOC/RESLOC?
Row 1:
Shows one or more lesions have been identified in the lower limb region.
Row 2:
Shows the location of the lesion in the native vessel.
Row 3:
Shows the location of the lesion is in the FEMORO-POPLITEAL graft.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTEST
TULOC
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
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
2
TUDY01
TU
40912
2
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
POPLITEAL ARTERY
LEFT
ABOVE KNEE
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Graft Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
LEFT FEMORO-POPLITEAL GRAFT
LEFT
PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
Dataset Debug Messages
There is a leading, trailing, or non-breaking space in the dataset.