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

Autor:	Krishnan P; 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)., Farhan S; 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)., Zidar F; Department of Cardiology, Austin Heart, TX (F.Z.)., Krajcer Z; Department of Vascular Surgery, Texas Heart Institute, Houston (Z.K.)., Metzger C; Department of Cardiology, Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.)., Kapadia S; Department of Cardiology, Cleveland Clinic, OH (S. Kapadia)., Moore E; Department of Vascular Surgery, River City Clinical Research, Jacksonville, FL (E.M.)., Nazif T; Department of Cardiology, Columbia University, New York, NY (T.N.)., Garland T; Department of Vascular Surgery, Vascular Institute of the Rockies, Denver, CO (T.G.)., Zhang M; Department of Cardiology, Swedish Medical Center, Seattle, WA (M.Z.)., Khera S; 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)., Sharafuddin M; Department of Vascular Surgery, University of Iowa, Iowa City (M.S.)., Patel VI; New York Presbyterian, Columbia University, New York, NY (V.I.P.)., Bacharach JM; North Central Heart, Sioux Falls, SD (J.M.B.)., Coady P; Department of Cardiology, Lankenau Medical Center, Wynnewood, PA (P.C.)., Schermerhorn ML; Department of Vascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA (M.L. Schermerhorn)., Shames ML; Department of Vascular Surgery, University of South Florida, Tampa (M.L. Shames)., Rahimi S; Department of Vascular Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (S.R.)., Panneton JM; Department of Vascular Surgery, Sentara Vascular Specialists, Norfolk, VA (J.P.)., Elkins C; Department of Vascular Surgery, INTEGRIS Baptist Medical Center, Oklahoma City, OK (C.E.)., Foteh M; Department of Vascular Surgery, Cardiothoracic and Vascular Surgeons, Austin, TX (M.F.).
Jazyk:	angličtina
Zdroj:	Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2024 Jun; Vol. 17 (6), pp. e013842. Date of Electronic Publication: 2024 May 06.
DOI:	10.1161/CIRCINTERVENTIONS.123.013842
Abstrakt:	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. Competing Interests: Disclosures Dr Krishnan has served as a consultant to Abbott and Medtronic. Dr Nazif reports consulting fees or honoraria from Terumo Medical, Boston Scientific, Medtronic, Edwards Lifesciences, Teleflex, Opsens Medical, Encompass Technologies, and Columbia University Irving Medical Center. The other authors report no conflicts.
Databáze:	MEDLINE
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