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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 angioplasty (percutaneous vascular intervention), 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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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR409121

Peripheral Artery Bypass Graft

Prior Intervention1SCREEN2007-01-01

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:

  1. The native vessel on which the bypass graft was built - row 1.
  2. The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
  3. 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.

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Row

STUDYID

DOMAIN

USUBJID

FASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

1TUDY01FA409121Graft Vessel Construction LocationPeripheral Artery Bypass GraftPrior Intervention

Left Femoral-popliteal Artery

1SCREEN2007-01-01
2TUDY01FA409122

Bypass Graft Type

Peripheral Artery Bypass GraftPrior Intervention

Cardaveric Graft, Venous

1SCREEN2007-01-01
3TUDY01FA409123Graft Anastomosis (connection) LocationPeripheral Artery Bypass GraftPrior InterventionLeft Common femoral Artery1SCREEN2007-01-01
4TUDY01FA409124

Graft Anastomosis (connection) Location

Peripheral Artery Bypass GraftPrior InterventionLeft Popliteal Artery1SCREEN2007-01-01
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

On 2007-01-01, 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 (lesion 2) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, lesion 2 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 (Lesion 2). 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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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
1

TUDY01

PR409121CT PERIPHERAL ANGIOGRAPHYPREOPERATIVE DIAGNOSTIC2VISIT 12007-02-07

2007-01-01T08:00

2007-01-01T09:00
2

TUDY01

PR409122

Cardiac Catheterization

PVI2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00
3

TUDY01

PR409123Stent ImplantationPVI2VISIT 12007-02-07

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.
Row 3:Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 4:Shows the lesion is found in the left popliteal artery, in the segment above the knee.
Row 5:Shows the major vessel that contains a lesion is the femoro-popliteal graft.
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).
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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Row

STUDYID

DOMAIN

USUBJID

TUSEQTULNKID

TUTEST

TULOC

TULATTULOCDTL

TUORRES

TUSTRESCTU Result LOCTU Result LATTU Result LOCDTL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC

1

TUDY01

TU409121
Lesion IndicatorLOWER LIMB REGION

YY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
2

TUDY01

TU409122Limb 1Limb with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEGLEFT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
3

TUDY01

TU409123Vessel 1-Lesion 1Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDFEMORO-POPLITEAL PERIPHERAL ARTERYLEFT
CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
4

TUDY01

TU409124Lesion 1Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDPOPLITEAL ARTERYLEFTABOVE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
5

TUDY01

TU409125Graft Vessel 1-Lesion 2Vessel with Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT

CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
6

TUDY01

TU409126Lesion 2Lesion Location IdentificationLOWER LIMB REGION

LOCATEDLOCATEDLEFT FEMORO-POPLITEAL GRAFT
ANASTOMOSIS PROXIMAL,  5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
6

TUDY01

TU409126Lesion 2Graft Lesion Location IdentificationLEFT FEMORO-POPLITEAL GRAFT

LOCATEDLOCATEDGRAFT ANASTOMOSIS PROXIMAL
5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
7

TUDY01

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


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
8

TUDY01

TU409128Lesion 1

Lesion Role Identification

POPLITEAL ARTERYLEFTABOVE KNEENON-TARGETNON-TARGET


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
9
TU409129Graft Vessel 1-Lesion 2Vessel with Lesion Role IdentificationLEFT FEMORO-POPLITEAL GRAFTLEFT
TARGETTARGET


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
10

TUDY01

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


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
11

TUDY01

TU4091211Limb 1Limb with Lesion Role IdentificationLEGLEFT
TARGETTARGET


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

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.

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.

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Row

STUDYID

DOMAIN

USUBJID

TRSEQTRGRPID

TRLNKID

TRTEST

TRORRES

TRSTRESC

VISITNUM

VISIT

TRDTC

1

TUDY01

TR409121TARGETLesion 2Lesion Failure IndicatorNN2VISIT 12007-02-07
3

TUDY01

TR409123TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorNN2VISIT 12007-02-07
4

TUDY01

TR409124TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

YY2VISIT 12007-02-07
5

TUDY01

TR409125TARGETLimb 1Limb Failure IndicatorNN2VISIT 12007-02-07
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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.

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Row

STUDYID

DOMAIN

USUBJID

RSSEQRSGRPID

RSLNKID

RSTEST

RSCATRSORRES

RSSTRESC

VISITNUM

VISIT

RSDTC

1

TUDY01

RS409121TARGETLesion 2Lesion Failure IndicatorACC/AHA Clinical Data Standards 2014NN2VISIT 12007-02-07
2

TUDY01

RS409121TARGETGraft Vessel 1-Lesion 2Vessel Failure IndicatorACC/AHA Clinical Data Standards 2014NN2VISIT 12007-02-07
3

TUDY01

RS409121TARGETGraft Vessel 1-Lesion 2

Vessel Patency Indicator

ACC/AHA Clinical Data Standards 2014YY2VISIT 12007-02-07
4

TUDY01

RS409121TARGETLimb 1-Lesion 2Limb Failure IndicatorACC/AHA Clinical Data Standards 2014NN2VISIT 12007-02-07
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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