Prakash Krishnan, Serdar Farhan, Frank Zidar, Zvonimir Krajcer, Christopher Metzger, Samir Kapadia, Erin Moore, Tamim Nazif, Ty Garland, Ming Zhang, Sahil Khera, Mel Sharafuddin, Virendra I Patel, John Michael Bacharach, Paul Coady, Marc L Schermerhorn, Murray L Shames, Saum Rahimi, Jean M Panneton, Craig Elkins, Mazin Foteh
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This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths.</p><p><strong>Methods: </strong>The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure.</p><p><strong>Results: </strong>A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. 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引用次数: 0
摘要
背景：越来越多的介入手术需要使用大鞘技术（>12F），使用血管内入路比开放手术入路效果更好。然而，血管并发症限制了对这些患者的管理。这项试验旨在确定 Cross-Seal 缝合血管闭合器在使用 8F 至 18F 手术鞘进行介入手术后在目标肢体入路部位止血的有效性和安全性：Cross-Seal IDE 试验（研究设备豁免）是一项前瞻性、单臂、多中心研究，对象是使用 8F 至 18F ID 程序鞘进行经皮血管内介入手术的受试者。主要疗效终点是目标肢体入路部位的止血时间。主要安全性终点是术后30天内目标肢体入路部位无主要并发症：在2019年8月9日至2020年3月12日期间，共有147名受试者入组。53.7%（79/147）的受试者进行了经导管主动脉瓣置换术，46.3%（68/147）的受试者进行了经皮血管内腹/胸主动脉瘤修补术。平均鞘内径为 15.5±1.8 毫米。止血时间的主要有效性终点为 0.4±1.4 分钟。9.2%的受试者（13/142）需要辅助干预，其中2.1%（3/142）为外科手术，5.6%（8/142）为血管内手术。92.3%的受试者（131/142）获得了技术成功。目标肢体入路部位无重大并发症的比例为94.3%（83/88）：Cross-Seal缝合血管闭合器在使用8F至18F ID手术鞘进行经皮血管内手术的选定患者中，在闭合大口径动脉切口方面取得了良好的效果和安全性：URL：https://www.clinicaltrials.gov；唯一标识符：NCT03756558。
Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.
Background: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths.
Methods: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure.
Results: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88).
Conclusions: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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