The CLOSER trial: a multi-center study on the clinical safety and effectiveness of closer<sup>TM</sup> VSS, a novel resorbable transfemoral vascular access sealing system.

MedStar author(s):
Citation: Catheterization & Cardiovascular Interventions. 90(5):798-805, 2017 Nov 01.PMID: 28833996Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Catheterization, Peripheral/mt [Methods] | *Femoral Artery | *Hemorrhage/pc [Prevention & Control] | *Hemostatic Techniques/is [Instrumentation] | *Vascular Closure Devices | Aged | Catheterization, Peripheral/ae [Adverse Effects] | Equipment Design | Female | Femoral Artery/dg [Diagnostic Imaging] | Hemorrhage/et [Etiology] | Hemostatic Techniques/ae [Adverse Effects] | Humans | Intention to Treat Analysis | Length of Stay | Male | Middle Aged | Patient Discharge | Prospective Studies | Punctures | Risk Factors | Time Factors | Treatment Outcome | United StatesYear: 2017Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006ISSN:
  • 1522-1946
Name of journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsAbstract: BACKGROUND: Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures.CONCLUSIONS: In patients undergoing 5-7 Fr transfemoral diagnostic and interventional procedures, the CLOSER Trial met both its primary effectiveness and safety PGs. Immediate hemostasis was achieved in the majority of patients without major complication. Copyright (c) 2017 Wiley Periodicals, Inc.METHODS: In this prospective single-arm, multi-center trial, we compared the clinical outcomes in patients undergoing 5-7 Fr transfemoral diagnostic or interventional procedures and access sites managed with Closer VSS against pre-specified PGs. The primary endpoints were time to hemostasis (TTH) and 30-day access site closure-related major complications; secondary endpoints included time to ambulation (TTA), time to discharge eligibility (TTDE), time to discharge (TTD), 30-day access site minor complications, procedure and device success.OBJECTIVES: To evaluate the safety and effectiveness of the Closer Vascular Sealing System (VSS) against prespecified performance goals (PGs) in sealing femoral arterial access following 5-7 Fr procedures.RESULTS: A total of 220 subjects (49.5% interventional) were enrolled. The mean TTH was 1.78+/-7.81 min in the intention to treat and 0.98+/-3.71 min in the per protocol cohort. Median TTH was 0 min with immediate hemostasis achieved in 80.5% of subjects, mean TTA was 2.50+/-1.05 hr, and mean TTDE was 2.83+/-1.54 hr. Thirty-day follow-up was completed on 219 subjects. There were no access site closure-related major complications, minor complication rate was 0.0% for diagnostic and 2.75% for interventional procedures.All authors: Bachinsky W, Bergman G, Bernardo N, Cavros N, Gammon R, Jaff MR, Leimbach W, Liu PY, O'Shaughnessy C, Wong SCOriginally published: Catheterization & Cardiovascular Interventions. , 2017 Aug 23Fiscal year: FY2018Digital Object Identifier: Date added to catalog: 2017-08-29
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 28833996 Available 28833996

Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006

BACKGROUND: Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures.

CONCLUSIONS: In patients undergoing 5-7 Fr transfemoral diagnostic and interventional procedures, the CLOSER Trial met both its primary effectiveness and safety PGs. Immediate hemostasis was achieved in the majority of patients without major complication. Copyright (c) 2017 Wiley Periodicals, Inc.

METHODS: In this prospective single-arm, multi-center trial, we compared the clinical outcomes in patients undergoing 5-7 Fr transfemoral diagnostic or interventional procedures and access sites managed with Closer VSS against pre-specified PGs. The primary endpoints were time to hemostasis (TTH) and 30-day access site closure-related major complications; secondary endpoints included time to ambulation (TTA), time to discharge eligibility (TTDE), time to discharge (TTD), 30-day access site minor complications, procedure and device success.

OBJECTIVES: To evaluate the safety and effectiveness of the Closer Vascular Sealing System (VSS) against prespecified performance goals (PGs) in sealing femoral arterial access following 5-7 Fr procedures.

RESULTS: A total of 220 subjects (49.5% interventional) were enrolled. The mean TTH was 1.78+/-7.81 min in the intention to treat and 0.98+/-3.71 min in the per protocol cohort. Median TTH was 0 min with immediate hemostasis achieved in 80.5% of subjects, mean TTA was 2.50+/-1.05 hr, and mean TTDE was 2.83+/-1.54 hr. Thirty-day follow-up was completed on 219 subjects. There were no access site closure-related major complications, minor complication rate was 0.0% for diagnostic and 2.75% for interventional procedures.

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