CV Endpoint TAUG Example 1

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).

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?

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.

Lesion Location Identification

The below data show Locations of the lesions.

Question: Can we use LOC for Graft locations? LOC in most findings domains is supposed to be the location where a test is performed, and RESLOC is where a result is collected. SDTM does not specify that the location needs to be a "naturally occurring" body part, so can we get away with mapping graft locations into LOC/RESLOC?

Lesion Role Identification

The below example shows "role" assessment on the lesions that were identified.

Using a NSV to indicate the TULOC contains a graft location.

Mapping graft directly into TULOC.