No link could be created for 'Graft Lesion Concept Map'.
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
Cardaveric 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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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.
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.
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. Note TULNKID is created for this record because this limb will undergo "role" assessment and disease response to treatment assessment.
Row 3:
Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. Note TULNKID is created for this record because this affected vessel will undergo "role" assessment and disease response to treatment assessment.
Row 4:
Shows the lesion is found in the left popliteal artery, in the segment above the knee. Note TULNKID is created for this record because this lesion will undergo "role" assessment and disease response to treatment assessment.
Row 5:
Shows the major vessel that contains a lesion is the femoro-popliteal graft. Note TULNKID is created for this record.
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). Note TULNKID is created for this record.
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)
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, 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.