Isostent for Restenosis Intervention Study - IRIS - 1998
Radioactive P32 stent for native or restenotic coronary lesions
To determine the safety of implanting radioactive Palmaz-Schatz coronary stents.
Patients Screened: Not given
Patients Enrolled: 25
Mean Follow Up: 6 months
Native coronary lesions
De novo or restenotic lesions
Vessel size 3.0-3.5 mm
Lesion length < 28 mm
30-day major adverse events
Binary restenosis at 6 months; IVUS for intimal hyperplasia
Palmaz-Schatz coronary stents embedded with P32
Aspirin and ticlopidine for 30 days following stent placement
The expansion phase of the IsoStents for Restenosis Intervention Study (IRIS) is designed to determine the safety of implanting Palmaz-Schatz coronary stents with a level of radioactivity (0.75 μCi-1.50 μCi) above the original feasibility study (0.50 μCi-1.00 μCi). Average stent activity was 1.06 μCi at implant.
Twenty-seven radioisotope stents were successfully implanted in de novo (n = 22) or restenotic (n = 3) lesions in 25 patients (LAD = 11, Circ = 7, RCA = 7).
At 30 days, no patients had vessel closure, any MI, target vessel revascularization, death or neutropenia.
P32 radioisotope stents can be safely implanted with a high immediate success rate and no unexpected adverse events at one month.
1. J Am Coll Cardiol 1998;31(2):350A. Preliminary results
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Feasibility Studies, Neutropenia, Radioisotopes, Coronary Disease, Angioplasty, Balloon, Coronary, Stents
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