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Inari Medical宣布PEERLESS II随机对照试验(RCT)首次患者入组

Inari Medical Announces First Patient Enrollment in PEERLESS II Randomized Controlled Trial (RCT)

GlobeNewswire 等信源发布 2023-11-28 05:20

可切换为仅中文


IRVINE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced the first patient enrollment in the PEERLESS II study. This prospective, global, multi-center randomized controlled trial (“RCT”) compares the outcomes of intermediate-risk acute pulmonary embolism (“PE”) patients treated with the FlowTriever® System against those treated with traditional anticoagulation therapy alone.

IRVINE,CA,2023年11月27日(GLOBE NEWSWIRE)-Inari Medical,Inc。(纳斯达克股票代码:NARI)(“Inari”),一家医疗器械公司,致力于治疗和改变患者的生活今天宣布第一名患者参加无同伴II研究的静脉和其他疾病。这项前瞻性,全球性,多中心随机对照试验(“RCT”)比较了使用FlowTriever®系统治疗的中危急性肺栓塞(“PE”)患者与仅使用传统抗凝治疗的患者的预后。

The first patient was enrolled by Dr. William H. Matthai, Jr., Director of Clinical Cardiology Research and Professor of Clinical Medicine (Cardiovascular Medicine) at Penn Presbyterian Medical Center at the University of Pennsylvania. 'PEERLESS II is challenging the most commonly administered first-line therapy for PE around the world,” said Dr.

第一名患者由宾夕法尼亚大学宾夕法尼亚长老会医学中心临床心脏病学研究主任,临床医学(心血管医学)教授William H.Matthai博士注册Dr.Dr.博士说,无皮II正在挑战全球PE最常用的一线治疗方法。

Matthai. “Despite advances in mechanical thrombectomy, anticoagulation alone remains the standard of care. This trial aims to generate definitive evidence to influence PE treatment guidelines worldwide.' PEERLESS II is the largest study of its kind and will include up to 1,200 randomized patients at up to 100 global centers.

Matthai。“尽管机械性血栓切除术取得了进展,但抗凝治疗仍然是治疗的标准,该试验旨在为全球范围内的PE治疗指南提供明确的证据。”PEERLESS II是同类研究中最大的一项,将包括多达1200名随机患者,最多100个全球中心。

The study is running alongside the currently enrolling PEERLESS RCT, which is comparing FlowTriever to catheter-directed thrombolysis. Both trials aim to generate the high-quality clinical evidence needed to move the field forward and establish FlowTriever as the optimal therapy for intermediate-risk PE patients.

该研究与目前正在进行的无同伴RCT一起进行,该RCT正在比较FlowTriever和导管定向溶栓。两项试验均旨在产生推动该领域向前发展所需的高质量临床证据,并建立FlowTriever作为中危PE患者的最佳治疗方案。

'PE is a leading cause of cardiovascular death and this first patient enrollment represents an important milestone in the evolution of care for this disease,” added Global Principal Investigator Dr. Jay Giri, Director of the Cardiovascular Catheter.

全球首席研究员Jay Giri博士补充说:“PE是导致心血管死亡的主要原因,首次入选患者是该疾病护理发展的重要里程碑。”。