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.
The CLOSER trial: a multi-center study on the clinical safety and effectiveness of closerTM VSS, a novel resorbable transfemoral vascular access sealing system.
- 2017
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.
English
1522-1946
*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 States
MedStar Heart & Vascular Institute
Journal Article
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.
English
1522-1946
*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 States
MedStar Heart & Vascular Institute
Journal Article