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Purpose: To report an interim analysis of whether centered endovascular irradiation with the iridium 192 ((192)Ir) source immediately after percutaneous transluminal angioplasty (PTA) of de novo femoropopliteal stenoses lowers the restenosis rate., Materials and Methods: Thirty patients undergoing PTA to treat femoropopliteal stenoses were randomized for prophylaxis against restenosis with centered endovascular irradiation with a (192)Ir source (a dose of 14 Gy 2 mm deep to the vessel wall, irradiation group) or no irradiation (control group). Angiographic follow-up was available for 22 patients at 6 months (irradiation group, n = 10) and 12 patients at 12 months (irradiation group, n = 6). Duplex sonography, treadmill testing, and interviews were performed the day before and the day after PTA and after 1, 3, 6, 9, and 12 months. Results of angiography, duplex sonography, treadmill testing, and interviews were evaluated with a t test and multivariate analysis of variance (clinical characteristics, chi(2) test)., Results: Baseline characteristics were comparable in the two groups. Interim analysis of the 6-month follow-up data revealed a trend toward a significantly lower restenosis rate in the irradiation group. The change in the degree of stenosis compared with that after PTA was -14.7% +/- 20.8 (mean +/- SD) in the irradiation group versus 37.7% +/- 27.3 in the control group (P =.001) and became even more marked at 12 months (-9.5% +/- 34.5 vs 45.5% +/- 40.7 [P =.03], respectively). The follow-up results of treadmill testing and interviews showed a nonsignificant benefit for the irradiation group. One thromboembolic complication occurred during irradiation. No side effects were observed during follow-up., Conclusion: Endovascular irradiation with a centered (192)Ir source immediately after PTA of de novo femoropopliteal stenoses reduces the restenosis rate., (Copyright RSNA, 2002)

Objectives: To evaluate the performance and efficacy of endovascular irradiation after percutaneous transluminal angioplasty (PTA) of de-novo femoropopliteal stenoses in a pilot study., Methods: 6 patients received non-centered endovascular irradiation (12 Gray at surface of the vessel wall) immediately after angioplasty of de-novo femoropopliteal stenosis, 1 patient was given centered endovascular irradiation using 192-iridium (12 Gray at surface of the vessel wall) Centered irradiation was considered for two other patients. Duplex sonographies and interviews were performed the day before and after PTA and after 1, 3, 6, 9, 12, 18, 24 months up to 4 years. Intraarterial angiography was performed in symptomatic patients., Results: Non-centered endovascular irradiation was possible in all patients without problems or complications. Centered irradiation was not possible in two patients with the cross-over approach. One thromboembolic complication occurred during centered irradiation. Both restenosis and new stenosis at the edge of irradiated distance occurred in 1/7 patients. No other side effects were observed during follow-up., Conclusions: In our pilot study endovascular irradiation after angioplasty of de-novo femoropopliteal stenosis was possible with low rates of complications and restenosis and taking vessel anatomy into account.