Premium
The CLOSER trial: a multi‐center study on the clinical safety and effectiveness of Closer TM VSS, a novel resorbable transfemoral vascular access sealing system
Author(s) -
Wong S. Chiu,
Gammon Roger,
Bachinsky William,
O'Shaughnessy Charles,
Leimbach Wayne,
Bernardo Nelson,
Cavros Nick,
Jaff Michael R.,
Liu PingYu,
Bergman Geoffrey
Publication year - 2017
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27241
Subject(s) - medicine , hemostasis , vascular closure device , surgery , single center , clinical trial , clinical endpoint , vascular access , prospective cohort study , cohort , complication , randomized controlled trial , hemodialysis
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. Background Inconsistent safety profiles, costs and learning curves of earlier generation vascular closure devices have limited their widespread use following transfemoral procedures. 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. 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. 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.