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Subject 40912 had a previous peripheral artery bypass surgery that took place on 2006-12-16

LEFT
Dataset wrap
titlecv.xpt
NameTUPR
Rowcaps
Row 1:A peripheral angiography
Rows 3-4:I examined the image of the thoracic region (test location) and found that the descending aorta (result location) had dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area.
Rows 5-6:I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (result location), proximal to the iliac bifurcation (result location detail). In this case result location detail is a variable qualifier for the result, I am trying to say that the aneurysm is located in the segment of the infrarenal aorta closer (proximal) to the iliac bifurcation.
Rows 7-8:I examined the image of the abdominal region (test location) and found that the infrarenal aorta (result location) had dissected.
Dataset2
hi1style#e3fcef
hi210,11,12,13
hi12,4,6,8
hi3TURESLOC
hi2styleyellow
hi3styleBOLD
tableidTU1

Row

STUDYID

DOMAIN

USUBJID

TUSEQ

TUGRPID

TULNKID

FATEST

FAOBJ

FAORRES
TURESLATTU RESLOC Detail

TUMETHOD

VISITNUM

VISIT

TUDTC

Graft Construction LocationFEMORO-POPLITEAL PERIPHERAL ARTERYLEFTGraft Anastomosis (connection) LocationLCOMMON FEMORAL ARTERYLEFT

Graft Anastomosis (connection) Location

POPLITEAL ARTERY


Dataset2


Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRSTDTCPRENDTC
 1

TUDY01

PR409121CORONARY ARTERY BYPASS GRAFTPRIOR SURGERY1SCREEN

2006-12-16T06:00

2006-12-16T08:00




Dataset wrap
titlecv.xpt
Namefapr


Rowcaps


Row 1:Shows the graft vessel is built on the LEFT FEMORO-POPLITEAL ARTERY.
Row 2:Shows the bypass graft type is 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 are on the LEFT COMMON FEMORAL ARTERY and LEFT POPLITEAL ARTERY.



Dataset2
hi2styleyellow


Row

STUDYID

DOMAIN

USUBJID

FASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

1TUDY01FA409121Graft Construction LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT FEMORO-POPLITEAL ARTERY1SCREEN2006-12-16
2TUDY01FA409122

Bypass Graft Type

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERY

CADAVERIC GRAFT, VENOUS

1SCREEN2006-12-16
3TUDY01FA409123Graft Anastomosis (connection) LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT COMMON FEMORAL ARTERY1SCREEN2006-12-16
4TUDY01FA409124

Graft Anastomosis (connection) Location

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT POPLITEAL ARTERY1SCREEN2006-12-16




Two lesions are located


Dataset wrap
titlecv.xpt
NameTU


Rowcaps


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.)



Dataset2


Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TULATTULOCDTL

TUORRES

TUSTRESCTURESLOC
TURESLATTURLOCDL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGION

YY


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
2

TUDY01

TU409122Vessel 1-Lesion 1Native Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
3

TUDY01

TU409123Lesion 1Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEEPERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
4

TUDY01

TU409124Graft Vessel 1-Lesion 2Graft Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT

PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
5

TUDY01

TU409125Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFT

LOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL
5MM FROM THE ORIGIN OF THE GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
6

TUDY01

TU409126Limb 1-Lesion 2Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
7

TUDY01

TU409127Vessel 1-Lesion 1Native Vessel with Lesion Role IdentificationFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
NON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
8

TUDY01

TU409128Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
9

TUDY01

TU409129Graft Vessel 1-Lesion 2Graft Vessel with Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFT VESSELLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
10

TUDY01

TU4091210Lesion 2Graft Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTGRAFT ANASTOMOSIS PROXIMAL
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1SSCREENBASELINE2007-02-01
11

TUDY01

TU4091211Limb 1-Lesion 2Limb with Lesion Role IdentificationLEGLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR1BASELINE2007-02-01



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.

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titlecv.xpt
NameTR


Rowcaps


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.



Dataset2
hi1style#e3fcef
hi1TRLOC
tableidTR1


Row

STUDYID

DOMAIN

USUBJID

TRSEQTRGRPID

TRLNKID

TRTEST

TRORRES

TRSTRESC

TRMETHOD

VISITNUM

VISIT

CVDTC

1

TUDY01

TR409121
SSCREEN
TARGETLesion 2Lesion Failure IndicatorNNPERIPHERAL ANGIOGRAPHY1BASELINE2007-02-01
3

TUDY01

TR409123TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorNNPERIPHERAL ANGIOGRAPHY1BASELINE2007-02-01
4

TUDY01

TR409124TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

YYPERIPHERAL ANGIOGRAPHY1BASELINE2007-02-01
5

TUDY01

TR409125TARGETLimb 1-Lesion 2Limb Failure IndicatorNNPERIPHERAL ANGIOGRAPHY1BASELINE2007-02-01



I think this should be modeled in RS in the following fashion, similar to that of Tumor response to treatment modeling in RS.

Dataset wrap
titlecv.xpt
NameRS


Rowcaps


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.



Dataset2


Row

STUDYID

DOMAIN

USUBJID

RSSEQRSGRPID

RSLNKID

RSTEST

RSCATRSORRES

RSSTRESC

VISITNUM

VISIT

CVDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorACC/AHA Clinical Data Standards 2014NN1BASELINE2007-02-01
2

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorACC/AHA Clinical Data Standards 2014NN1BASELINE2007-02-01
3

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

ACC/AHA Clinical Data Standards 2014YY1BASELINE2007-02-01
4

TUDY01

TR409121TARGETLimb 1-Lesion 2Limb Failure IndicatorACC/AHA Clinical Data Standards 2014NN1BASELINE2007-02-01