Twelve‐month safety and effectiveness of TCD‐17187 drug‐coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery
| العنوان: | Twelve‐month safety and effectiveness of TCD‐17187 drug‐coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery |
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| المؤلفون: | Osamu, Iida, Yoshimitsu, Soga, Shu-Ichi, Seki, Daizo, Kawasaki, Hitoshi, Anzai, Hiroshi, Ando, Tatsuya, Nakama, Norihiko, Shinozaki, Amane, Kozuki, Masaharu, Ishihara, Kazushi, Urasawa, Satoru, Toi, Hiroaki, Tsujita, Kazuki, Tobita, Kenji, Ogata, Kazunori, Horie, Naoki, Hayakawa, Shinsuke, Mori, Masahiko, Fujihara, Takao, Ohki, Kenichiro, Yuba, Toshiaki, Mano, Masato, Nakamura |
| المصدر: | Catheterization and Cardiovascular Interventions. 100:1100-1109 |
| بيانات النشر: | Wiley, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Aged, 80 and over, Femoral Artery, Peripheral Arterial Disease, Treatment Outcome, Humans, Popliteal Artery, Radiology, Nuclear Medicine and imaging, Prospective Studies, General Medicine, Atherosclerosis, Cardiology and Cardiovascular Medicine, Aged |
| الوصف: | The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA).This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up.Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period.This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA. |
| تدمد: | 1522-726X 1522-1946 |
| DOI: | 10.1002/ccd.30408 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4e740ee3f91ce5131d7386d5832d05ed https://doi.org/10.1002/ccd.30408 |
| Rights: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....4e740ee3f91ce5131d7386d5832d05ed |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1522726X 15221946 |
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| DOI: | 10.1002/ccd.30408 |