Isostent for Restenosis Intervention Study - IRIS - 1998

Description:

Radioactive P32 stent for native or restenotic coronary lesions

Hypothesis:

To determine the safety of implanting radioactive Palmaz-Schatz coronary stents.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 25
Mean Follow Up: 6 months

Patient Populations:

Native coronary lesions
De novo or restenotic lesions
Vessel size 3.0-3.5 mm
Lesion length < 28 mm

Primary Endpoints:

30-day major adverse events

Secondary Endpoints:

Binary restenosis at 6 months; IVUS for intimal hyperplasia

Drug/Procedures Used:

Palmaz-Schatz coronary stents embedded with P32

Concomitant Medications:

Aspirin and ticlopidine for 30 days following stent placement

Principal Findings:

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.

Interpretation:

P32 radioisotope stents can be safely implanted with a high immediate success rate and no unexpected adverse events at one month.

References:

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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