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Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16.

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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR409121CORONARY ARTERY BYPASS GRAFTPRIOR SURGERY1SCREEN2007-01-01

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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STUDYID

DOMAIN

USUBJID

FASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

1TUDY01FA409121Graft Construction LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT FEMORO-POPLITEAL ARTERY1SCREEN2007-01-01
2TUDY01FA409122

Bypass Graft Type

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERY

CADAVERIC GRAFT, VENOUS

1SCREEN2007-01-01
3TUDY01FA409123Graft Anastomosis (connection) LocationCORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT COMMON FEMORAL ARTERY1SCREEN2007-01-01
4TUDY01FA409124

Graft Anastomosis (connection) Location

CORONARY ARTERY BYPASS GRAFTPRIOR SURGERYLEFT POPLITEAL ARTERY1SCREEN2007-01-01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Two separate lesions are located in the left leg of the subject, one (Lesion 1) in the native FEMORO-POPLITEAL PERIPHERAL ARTERY, the other (lesion 2) in the FEMORO-POPLITEAL graft. Lesion 1 is considered as non-target, lesion 2 is considered as target.

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.

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STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TULATTULOCDTL

TUORRES

TUSTRESCTURESLOC
TURESLATTURLOCDL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGION

YY


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
2

TUDY01

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

LOCATEDLOCATEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
3

TUDY01

TU409123Lesion 1Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEEPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
4

TUDY01

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

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT

PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
5

TUDY01

TU409125Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFT

LOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL
5MM FROM THE ORIGIN OF THE GRAFTPERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
6

TUDY01

TU409126Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
7

TUDY01

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


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
8

TUDY01

TU409128Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
9

TUDY01

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


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
10

TUDY01

TU4091210Lesion 2Graft Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFT
GRAFT ANASTOMOSIS PROXIMALTARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01
11

TUDY01

TU4091211Limb 1Limb with Lesion Role IdentificationLEGLEFT
TARGETTARGET


PERIPHERAL ANGIOGRAPHYINVESTIGATOR2BASELINE2007-02-01

Dataset Debug Messages

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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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STUDYID

DOMAIN

USUBJID

TRSEQTRGRPID

TRLNKID

TRTEST

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TRMETHOD

VISITNUM

VISIT

CVDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
3

TUDY01

TR409123TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
4

TUDY01

TR409124TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

YYPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
5

TUDY01

TR409125TARGETLimb 1-Lesion 2Limb Failure IndicatorNNPERIPHERAL ANGIOGRAPHY2BASELINE2007-02-01
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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.

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Row

STUDYID

DOMAIN

USUBJID

RSSEQRSGRPID

RSLNKID

RSTEST

RSCATRSORRES

RSSTRESC

VISITNUM

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CVDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
2

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
3

TUDY01

TR409121TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

ACC/AHA Clinical Data Standards 2014YY2BASELINE2007-02-01
4

TUDY01

TR409121TARGETLimb 1-Lesion 2Limb Failure IndicatorACC/AHA Clinical Data Standards 2014NN2BASELINE2007-02-01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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