CV-endpoint Example 1, Peripheral Arterial Lesion

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	PRREFID	PRSEQ	PRTRT	PRLOC	PRLAT	PRCAT	VISITNUM	VISIT	PRDTC	PRSTDTC	PRENDTC
1	TUDY01	PR	40912	graft01	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.

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	FAREFID	FASEQ	FATEST	FAOBJ	FACAT	FAORRES	VISITNUM	VISIT	TUDTC
2	TUDY01	FA	40912	graft01	2	Bypass Graft Type	Peripheral Artery Bypass Graft	Prior Intervention	Cadaveric Graft, Venous	1	SCREEN	2007-01-01
3	TUDY01	FA	40912	graft01	3	Proximal Graft Anastomosis (connection) Location	Peripheral Artery Bypass Graft	Prior Intervention	Common femoral Artery	1	SCREEN	2007-01-01
4	TUDY01	FA	40912	graft01	4	Distal Graft Anastomosis (connection) Location	Peripheral Artery Bypass Graft	Prior Intervention	Popliteal Artery	1	SCREEN	2007-01-01

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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	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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Lesion Location Identification

Collection Date	Collection Date TUDAT TUDTC	_________________
	Anatomical Part or Region Shown by the Image TULOC Hidden/pre-populated	LOWER LIMB REGION
	Lesion Identification Test Name TUTEST Hidden/pre-populated	Lesion Indicator <TUTEST codelist>
	Was there a lesion present based on the assessment of the image? TUORRES	Yes No <Y/N codelist>
	Lesion Identification Test Name TUTEST Hidden/pre-populated	Examination for Abnormality <TUTEST codelist>
Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.	Lesion Type 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).	What was the location of the lesion based on the assessment of the image? 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	Yes
	If applicable, indicate the laterality of the location of the lesion. TURESLAT TURESLAT when TUTEST = ABNEXAM	_________________ <LAT codelist>
	If applicable, provide more detail of the location of the lesion. TURESLDL TURESLDL when TUTEST = ABNEXAM	_________________
Sponsor-specified	What was the Lesion ID? TULNKID TULNKID, TRLNKID, RSLNKID	_________________

Order	Type	CDASHIG Variable	Question Text	Prompt	CRF Completion Instructions	SDTMIG Target	Controlled Terminology Codelist Name	Implementation Notes	Permissible Values	Pre-populated Value	Query Display	List Style	Hidden
1	text	TUDAT	Collection Date		Collection Date	TUDTC	N/A				Prompt
2	text	TULOC	What 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
3	text	TUTEST	What 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
4	text	TUORRES	Was there a lesion present based on the assessment of the image?	Presence of Lesion		TUORRES	(Y/N)		Yes;No		redio
5	text	TUTEST	What 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
6	text	TUORRES	What was the type of lesion observed based on the assessment of the image?	Lesion Type	Record the type of lesion observed, e.g. aneurysm, calcified annulus, valvular stenosis, etc.	TUORRES when TUTEST = ABNEXAM					Prompt
7	text	TURESLOC	What was the location of the lesion based on the assessment of the image?	Result Anatomical Location	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 when TUTEST = ABNEXAM	(LOC)
8	text	TURLGFFL	Indicate whether the located lesion is in a graft or transplant.	Graft Result Location Flag	Check "Yes" for this question if the lesion is located in a graft (or transplant) tissue, organ or blood vessel.	NSTU.TURLGFFL			Yes			checkbox
9	text	TURESLAT	If applicable, indicate the laterality of the location of the lesion.	Result Location Laterality		TURESLAT when TUTEST = ABNEXAM	(LAT)
10	text	TURESLDL	If applicable, provide more detail of the location of the lesion.	Result Location directionality		TURESLDL when TUTEST = ABNEXAM	N/A
11	text	TULNKID	What was the Lesion ID?	Lesion ID	Sponsor-specified	TULNKID, TRLNKID, RSLNKID	N/A	This 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 the location of the lesion in the native vessel.
Row 3:	Shows the location of the lesion is 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	TUSEQ	TUREFID	TULNKID	TUTESTCD	TUTEST	TULOC	TUORRES	TUSTRESC	TU Result LOC	TU Result LAT	TU Result LOCDTL	TUMETHOD	TUEVEL	VISITNUM	VISIT	TUDTC	TURLGFFL
1	TUDY01	TU	40912	1			LESIONIND	Lesion Indicator	LOWER LIMB REGION	Y	Y				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	2		Lesion 1	ABNEXAM	Examination for Abnormality	LOWER LIMB REGION	LESION	LESION	POPLITEAL ARTERY	LEFT	ABOVE KNEE	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
3	TUDY01	TU	40912	3	graft01	Graft Lesion 1	ABNEXAM	Examination for Abnormality	LOWER LIMB REGION	LESION	LESION	FEMORO-POPLITEAL ARTERY	LEFT	PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07	Y

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TU NSV Metadata

Variable	Label	Type	Role	Origin
TURLGFFL	Result location is Graft Flag	text	Non-Standard Record Qualifier	CRF

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Prior and Current Procedures

Lesion Location Identification