Department of Cardiology, Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (P.K., S.F., S. Khera).
Department of Cardiology, Austin Heart, TX (F.Z.).
Circ Cardiovasc Interv. 2024 Jun;17(6):e013842. doi: 10.1161/CIRCINTERVENTIONS.123.013842. Epub 2024 May 6.
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.
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.
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).
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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.
越来越多的介入治疗需要使用大鞘技术（>12F），经血管内而非开放手术入路具有更好的效果。然而，血管并发症是这些患者治疗的一个限制。本试验旨在确定 Cross-Seal 缝合介导的血管闭合装置在使用 8F 至 18F 程序鞘进行介入治疗后，在目标肢体入路部位获得止血的有效性和安全性。
Cross-Seal IDE 试验（研究性器械豁免）是一项前瞻性、单臂、多中心研究，共纳入 147 例接受经皮血管内治疗程序使用 8F 至 18F ID 程序鞘的患者。主要疗效终点为目标肢体入路部位止血时间。主要安全性终点为术后 30 天内目标肢体入路部位无主要并发症。
2019 年 8 月 9 日至 2020 年 3 月 12 日期间共纳入 147 例患者。其中经导管主动脉瓣置换术 53.7%（79/147），经皮血管内腹主动脉/胸主动脉瘤修复术 46.3%（68/147）。平均鞘径为 15.5±1.8mm。主要有效性终点止血时间为 0.4±1.4 分钟。142 例（9.2%）患者需要辅助介入治疗，其中 2.1%（3/142）为手术，5.6%（8/142）为血管内。131 例（92.3%）患者技术成功。88 例（94.3%）患者目标肢体入路部位无重大并发症。
在接受使用 8F 至 18F ID 程序鞘的经皮血管内治疗程序的选定患者中，Cross-Seal 缝合介导的血管闭合装置在大口径动静脉切开术的闭合中取得了良好的有效性和安全性。
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