Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System-Reference-Cited by-同舟云学术

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

Published:2024-06 Issue:6 Volume:17 Page:
ISSN:1941-7640
Container-title:Circulation: Cardiovascular Interventions
language:en
Short-container-title:Circ: Cardiovascular Interventions

Author:

Krishnan Prakash¹^ORCID,Farhan Serdar¹,Zidar Frank²,Krajcer Zvonimir³,Metzger Christopher⁴,Kapadia Samir⁵^ORCID,Moore Erin⁶,Nazif Tamim⁷,Garland Ty⁸,Zhang Ming⁹,Khera Sahil¹^ORCID,Sharafuddin Mel¹⁰,Patel Virendra I.¹¹^ORCID,Bacharach John Michael¹²,Coady Paul¹³,Schermerhorn Marc L.¹⁴^ORCID,Shames Murray L.¹⁵,Rahimi Saum¹⁶,Panneton Jean M.¹⁷^ORCID,Elkins Craig¹⁸,Foteh Mazin¹⁹

Affiliation:

1. 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).

2. Department of Cardiology, Austin Heart, TX (F.Z.).

3. Department of Vascular Surgery, Texas Heart Institute, Houston (Z.K.).

4. Department of Cardiology, Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.).

5. Department of Cardiology, Cleveland Clinic, OH (S. Kapadia).

6. Department of Vascular Surgery, River City Clinical Research, Jacksonville, FL (E.M.).

7. Department of Cardiology, Columbia University, New York, NY (T.N.).

8. Department of Vascular Surgery, Vascular Institute of the Rockies, Denver, CO (T.G.).

9. Department of Cardiology, Swedish Medical Center, Seattle, WA (M.Z.).

10. Department of Vascular Surgery, University of Iowa, Iowa City (M.S.).

11. New York Presbyterian, Columbia University, New York, NY (V.I.P.).

12. North Central Heart, Sioux Falls, SD (J.M.B.).

13. Department of Cardiology, Lankenau Medical Center, Wynnewood, PA (P.C.).

14. Department of Vascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA (M.L. Schermerhorn).

15. Department of Vascular Surgery, University of South Florida, Tampa (M.L. Shames).

16. Department of Vascular Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (S.R.).

17. Department of Vascular Surgery, Sentara Vascular Specialists, Norfolk, VA (J.P.).

18. Department of Vascular Surgery, INTEGRIS Baptist Medical Center, Oklahoma City, OK (C.E.).

19. Department of Vascular Surgery, Cardiothoracic and Vascular Surgeons, Austin, TX (M.F.).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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