Trial Evaluates Rex Medical's Closer Vascular Sealing System
October 3, 2017—Results of the CLOSER trial evaluating the safety and effectiveness of the resorbable, transfemoral Closer vascular sealing system (Rex Medical) were published by S. Chiu Wong, MD, et al online ahead of print in Catheterization & Cardiovascular Interventions (CCI).
The investigators concluded that the CLOSER trial met both its primary effectiveness and safety performance goals with immediate hemostasis achieved in the majority of patients without major complication.
As summarized in CCI, this prospective single-arm, multicenter trial compared the clinical outcomes in patients undergoing 5-F to 7-F transfemoral diagnostic or interventional procedures and access sites managed with Closer vascular sealing system against prespecified performance goals.
The trial enrolled 220 patients (49.5% interventional). The primary endpoints were time to hemostasis (TTH) and 30-day access site closure-related major complications; secondary endpoints included time to ambulation, time to discharge eligibility, time to discharge, 30-day access site minor complications, and procedure and device success.
The mean TTH was 1.78 ± 7.81 minutes in the intention to treat cohort and 0.98 ± 3.71 minutes in the per protocol cohort. Median TTH was 0 minutes with immediate hemostasis achieved in 80.5% of patients. The mean time to ambulation was 2.5 ± 1.05 hours, and mean time to discharge eligibility was 2.83 ± 1.54 hours.
Thirty-day follow-up was completed on 219 patients. There were no access site closure-related major complications and the minor complication rate was 0% for diagnostic procedures and 2.75% for interventional procedures, reported the CLOSER investigators in CCI.