Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System

• Published in: Circulation. Cardiovascular interventions Vol. 17; no. 6; p. e013842
• Main Authors: Krishnan, Prakash, Farhan, Serdar, Zidar, Frank, Krajcer, Zvonimir, Metzger, Christopher, Kapadia, Samir, Moore, Erin, Nazif, Tamim, Garland, Ty, Zhang, Ming, Khera, Sahil, Sharafuddin, Mel, Patel, Virendra I., Bacharach, John Michael, Coady, Paul, Schermerhorn, Marc L., Shames, Murray L., Rahimi, Saum, Panneton, Jean M., Elkins, Craig, Foteh, Mazin
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.06.2024
• Subjects: Aged; Aged, 80 and over; Aortic Aneurysm, Abdominal - diagnostic imaging; Aortic Aneurysm, Abdominal - surgery; Aortic Aneurysm, Thoracic - diagnostic imaging; Aortic Aneurysm, Thoracic - surgery; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Catheterization, Peripheral - adverse effects; Catheterization, Peripheral - instrumentation; Endovascular Procedures - adverse effects; Endovascular Procedures - instrumentation; Equipment Design; Female; Hemorrhage - etiology; Hemorrhage - prevention & control; Hemostatic Techniques - adverse effects; Hemostatic Techniques - instrumentation; Humans; Male; Middle Aged; Prospective Studies; Punctures; Risk Factors; Suture Techniques - adverse effects; Suture Techniques - instrumentation; Time Factors; Transcatheter Aortic Valve Replacement - adverse effects; Transcatheter Aortic Valve Replacement - instrumentation; Treatment Outcome; Vascular Closure Devices; sutures; blood pressure; hemostasis; vascular closure devices
• ISSN: 1941-7640; 1941-7632; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.123.013842

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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.