[134353]
This pt enrolled in the phase i clinical safety trial of lutetium-texaphyrin (pci-0123) in the photodynamic treatment (photoangioplasty) of pts with peripheral arterial disease, (protocol pci-p135-9701). On april 22, 1998, the pt rec'd 2. 0 mg/kg (160 mg) of lutetium texaphyrin (pci-0123) injection, lot number 65401. Twenty-four hours later, on april 23, 1998, the pt returned for the arteriogram, "ivus", and photoangioplasty. Following the angiogram, the "ivus" was performed and a dissection of the right common iliac artery was noted during the "ivus" procedure. Since, in the opinion of the investigator, the dissection did not require immediate intervention, the cylindrical fiber optic diffuser device was introduced for the intraarterial illumination (photoangioplasty) of the superficial femoral artery as per protocol. Upon completion of the photoangioplasty treatment, the cylindrical fiber optic diffuser was withdrawn. It was noted that a distal fragment of the cylindrical fiber optic diffuser was broken with a fragment remaining in the right external iliac artery. In order to retrieve the fragment, the right common femoral artery was punctured using a micropuncture set. A 6-french sheath was then introduced, a 5-mm amplatz snare was then advanced, and the distal cylindrical fiber optic diffuser fragment in the right external iliac artery was retrieved via right groin approach. The dissected right common iliac artery, which was dissected during the "ivus" procedure, was then stented using a 10-mm x 4-cm symphony stent. Post-stent placement, a pelvic arteriogram was performed. The pt tolerated the procedure well, and there were no immediate post-procedural complications. The pt was admitted to the hosp for observation and was discharged the following day, april 24, 1998. The pt is scheduled for a follow up visit with his cardiologist one week after discharge. The principal investigator believes that it is likely that the adverse event (remaining fragment of cylindrical fiber optic diffuser) is related to the investigational cylindrical fiber optic diffuser device used to deliver light for photoangioplasty. Furhtermore, the principal investigator believes it is unlikely that the dissection that occurred during the "ivus" is related to the administration of lutetium-texaphyrin for photoangioplasty.
Patient Sequence No: 1, Text Type: D, B5