Wong SC, et al. – A trial was conducted to assess the safety as well as the efficacy of the Closer Vascular Sealing System (VSS) against prespecified performance goals (PGs) in sealing femoral arterial access following 5–7 Fr procedures. The CLOSER Trial met both its primary effectiveness and safety PGs in patients undergoing 5–7 Fr transfemoral diagnostic and interventional procedures. In the majority of patients, immediate hemostasis was achieved without major complication.

Methods

• Researchers performed a prospective single-arm, multi-center trial, wherein, they 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.
• Time to hemostasis (TTH) and 30-day access site closure-related major complications were the primary endpoints.
• 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

• This study included a total of 220 subjects (49.5% interventional).
• Findings showed that 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.
• Data also reported that 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.
• Researchers observed that there were no access site closure-related major complications, minor complication rate was 0.0% for diagnostic and 2.75% for interventional procedures.