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 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. 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)
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
Test Graft Location
Test Graft Location Detail
Result Graft Location
Result Graft Location Detail
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
Limb 1
Limb with Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
LEG
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Vessel 1-Lesion 1
Vessel with Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
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
5
TUDY01
TU
40912
5
Graft Vessel 1-Graft Lesion 1
Vessel with Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
See NSV
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
LEFT FEMORO-POPLITEAL GRAFT
6
TUDY01
TU
40912
6
Graft Lesion 1
Lesion Location Identification
LOWER LIMB REGION
IDENTIFIED
IDENTIFIED
See NSV
See NSV
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
LEFT FEMORO-POPLITEAL GRAFT
ANASTOMOSIS PROXIMAL, 5MM FROM THE ORIGIN OF THE GRAFT
7
TUDY01
TU
40912
7
Vessel 1-Lesion 1
Vessel with Lesion Role Identification
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
NON-TARGET
NON-TARGET
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
8
TUDY01
TU
40912
8
Lesion 1
Lesion Role Identification
POPLITEAL ARTERY
LEFT
ABOVE KNEE
NON-TARGET
NON-TARGET
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
9
TU
40912
9
Graft Vessel 1-Graft Lesion 1
Vessel with Lesion Role Identification
See NSV
TARGET
TARGET
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
LEFT FEMORO-POPLITEAL GRAFT
10
TUDY01
TU
40912
10
Graft Lesion 1
Lesion Role Identification
See NSV
See NSV
TARGET
TARGET
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
LEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMAL
11
TUDY01
TU
40912
11
Limb 1
Limb with Lesion Role Identification
LEG
LEFT
TARGET
TARGET
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
$warningHtml
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
VISITNUM
VISIT
TRDTC
1
TUDY01
TR
40912
1
TARGET
Graft Lesion 1
Lesion Failure Indicator
N
N
2
VISIT 1
2007-02-07
3
TUDY01
TR
40912
3
TARGET
Graft Vessel 1-Graft Lesion 1
Vessel Failure Indicator
N
N
2
VISIT 1
2007-02-07
4
TUDY01
TR
40912
4
TARGET
Graft Vessel 1-Graft Lesion 1
Vessel Patency Indicator
Y
Y
2
VISIT 1
2007-02-07
5
TUDY01
TR
40912
5
TARGET
Limb 1
Limb Failure Indicator
N
N
2
VISIT 1
2007-02-07
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Modeling the above TR data in RS, this is 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.
