Prior and Current Procedures

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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Row

STUDYID

DOMAIN

USUBJID

PRREFIDPRSEQ

PRTRT

PRLOCPRLATPRCATVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
 1

TUDY01

PR40912graft011

Peripheral Artery Bypass Graft

Femoral-popliteal ArteryLeftPrior 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.

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

FAREFIDFASEQ

FATEST

FAOBJFACATFAORRES

VISITNUM

VISIT

TUDTC

2TUDY01FA40912graft012

Bypass Graft Type

Peripheral Artery Bypass GraftPrior Intervention

Cadaveric Graft, Venous

1SCREEN2007-01-01
3TUDY01FA40912graft013Proximal Graft Anastomosis (connection) LocationPeripheral Artery Bypass GraftPrior InterventionCommon femoral Artery1SCREEN2007-01-01
4TUDY01FA40912graft014

Distal Graft Anastomosis (connection) Location

Peripheral Artery Bypass GraftPrior InterventionPopliteal Artery1SCREEN2007-01-01
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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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Row

STUDYID

DOMAIN

USUBJID

PRSEQ

PRTRT

PRCATPRLOCVISITNUM

VISIT

PRDTCPRSTDTCPRENDTC
1

TUDY01

PR409121CT PERIPHERAL ANGIOGRAPHYDIAGNOSTICLOWER EXTREMITIES2VISIT 12007-02-07

2007-01-03T08:00

2007-01-03T09:00

TUDY01

PR409122CT PERIPHERAL ANGIOGRAPHYPVI
2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00
2

TUDY01

PR409123

Cardiac Catheterization

PVI
2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00
3

TUDY01

PR409124Stent ImplantationPVI
2VISIT 12007-02-07

2007-01-05T07:00

2007-01-05T09:00
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Lesion Type and Location Identification



Collection Date
TUDAT TUDTC
_________________
TULOC
Hidden/pre-populated
LOWER LIMB REGION
TUTEST
Hidden/pre-populated
Lesion Indicator
<TUTEST codelist>
Was there a lesion present based on the assessment of the image?
TUORRES
<Y/N codelist>
TUTEST
Hidden/pre-populated
Examination for Abnormality
<TUTEST codelist>
Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.
TUORRES TUORRES when TUTEST = ABNEXAM
_________________
If this location is a graft (or transplant), enter the name of the native tissue, organ or blood vessel on which the graft is built (or in which the transplant is implanted).
TURESLOC TURESLOC when TUTEST = ABNEXAM
_________________
<LOC codelist>
Check "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel.Indicate whether the located lesion is in a graft or transplant.
TURLGFFL NSTU.TURLGFFL
TURESLAT TURESLAT when TUTEST = ABNEXAM
_________________
<LAT codelist>
TURESLDL TURESLDL when TUTEST = ABNEXAM
_________________
Sponsor-specified
TULNKID TULNKID, TRLNKID, RSLNKID
_________________
OrderTypeCDASHIG VariableQuestion TextPromptCRF Completion InstructionsSDTMIG TargetSDTMIG Variable MappingControlled Terminology Codelist NameImplementation NotesPermissible ValuesPre-populated ValueQuery DisplayList StyleHidden
1textTUDATCollection Date
Collection DateTUDTC
N/A


Prompt


2textTULOCWhat was the anatomical region shown by the imaging procedure?Anatomical Part or Region Shown by the Image
TULOC

This is the general anatomical part or region made available for assessment by the imaging procedure.
LOWER LIMB REGION

Y
3textTUTESTWhat was the
lesion
identification test
name?		Lesion
Identification
Test Name		Record the name of the TU
test, if not printed on the CRF.
If collected on the CRF, the
sponsor may provide additional
instructions to ensure the data
is entered as intended.		TUTEST
(TUTEST)Required to identify to which test the result relates. It is
recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.
Lesion Indicator

Y
4textTUORRESWas there a lesion present based on the assessment of the image?Presence of Lesion
TUORRES
(Y/N)
Yes;No
redio


5textTUTESTWhat was the
lesion
identification test
name?		Lesion
Identification
Test Name		Record the name of the TU
test, if not printed on the CRF.
If collected on the CRF, the
sponsor may provide additional
instructions to ensure the data
is entered as intended.		TUTEST
(TUTEST)Required to identify to which test the result relates. It is
recommended that test names be preprinted on the CRF rather than collected in a field that requires the site to enter text. If the form is laid out as a grid, then words such as Test can be included as the column header.
Examination for Abnormality

Y
6textTUORRESWhat was the type of lesion observed based on the assessment of the image?Lesion TypeRecord the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.TUORRES when TUTEST = ABNEXAM




Prompt


7textTURESLOCWhat was the
location of
the lesion based on the assessment of the image?		Result Anatomical LocationIf this location is a graft (or transplant), enter the name of the native tissue, organ or blood vessel on which the graft is built (or in which the transplant is implanted).TURESLOC when TUTEST = ABNEXAM
(LOC)






8textTURLGFFLIndicate whether the located lesion is in a graft or transplant.Graft Result Location FlagCheck "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel.NSTU.TURLGFFL


Yes

checkbox




9textTURESLATIf applicable, indicate the laterality of the location of the lesion.Result Location Laterality
TURESLAT when TUTEST = ABNEXAM
(LAT)






10textTURESLDLIf applicable, provide more detail of the location of the lesion.Result Location directionality
TURESLDL when TUTEST = ABNEXAM
N/A






11textTULNKIDWhat was the
Lesion ID?		Lesion IDSponsor-specifiedTULNKID, TRLNKID, RSLNKID
N/AThis variable is used to provide a unique code for each identified lesion in order to link records across related domains (TU, TR, RS).





The below data show lesion location identification from the diagnostic CT peripheral angiography procedure.

Row 1:Shows one or more lesions have been identified in the lower limb region.
Row 2:Shows lesion 1 is identified in the left popliteal artery above the knee.
Row 3:Shows graft lesion 1 is located 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.

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Row

STUDYID

DOMAIN

USUBJID

TUSEQTUREFIDTULNKIDTUTESTCD

TUTEST

TULOC

TUORRES

TUSTRESCTURESLOCTURESLATRLODTL

TUMETHOD

TUEVEL

VISITNUM

VISIT

TUDTC


TURLGFFL
1

TUDY01

TU409121

LESIONINDLesion IndicatorLOWER LIMB REGIONYY


CT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

2

TUDY01

TU409122
Lesion 1ABNEXAMExamination for AbnormalityLOWER LIMB REGIONLESIONLESIONPOPLITEAL ARTERYLEFTABOVE KNEECT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07

3

TUDY01

TU409123graft01Graft Lesion 1ABNEXAMExamination for AbnormalityLOWER LIMB REGIONLESIONLESIONFEMORO-POPLITEAL ARTERYLEFTPROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFTCT PERIPHERAL ANGIOGRAPHYINVESTIGATOR2VISIT 12007-02-07
Y

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

TU NSV Metadata

VariableLabelTypeRoleOrigin
TURLGFFLResult location is Graft FlagtextNon-Standard Record QualifierCRF

Dataset Wrapper Debug Message

Please add a row column to your dataset.

  File Modified
PDF File CV-endpoint data element.pdf Apr 26, 2021 by Jordan Li
Microsoft Powerpoint Presentation anatomy of lesion location and lesion treatment background intro.pptx Apr 26, 2021 by Jordan Li


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