Safety and Efficacy of the VASCADE MVP® XL Venous Vascular Closure System for Management of Femoral Venotomy Following Catheter-Based Interventions Utilizing 16-17F OD Sheaths: The AMBULATE EXPAND Trial.

BACKGROUND

With catheter-based interventions increasingly requiring large-bore venous access, reliable closure methods for 16-17F sheaths are essential. Current manual compression techniques can prolong recovery, delay ambulation and discharge candidacy, and cause patient discomfort. The VASCADE MVP XL Venous Vascular Closure System is designed to address this gap.

OBJECTIVE

The AMBULATE EXPAND trial was a prospective, single-arm, multi-center pivotal study designed to evaluate the safety and efficacy of the investigational device for closure of large-bore femoral venous access sites, and to generate evidence for customary regulatory review.

METHODS

This trial (February-September of 2025) enrolled patients undergoing non-emergent procedures requiring a single 16-17F outer diameter (OD) sheath and optional smaller sheaths. The primary efficacy endpoint was time to ambulation. The primary safety endpoint was the 30-day rate of major access-site complications. Secondary endpoints included time to hemostasis, total post-procedure time, discharge eligibility, device success, and 30-day rate of minor access-site complications.

RESULTS

A total of 77 patients were enrolled with none lost to follow-up. The study met both primary efficacy and safety endpoints. The mean time to ambulation was 3.2 h, and mean time to hemostasis was 2.7 min. The mean total post-procedure and time to discharge eligibility were 3.3 and 3.4 h, respectively. Device success was achieved in 98.7% of access sites. The primary safety endpoint of major venous access site closure-related complications over 30 days was 0%. Minor venous access site closure-related complications were also 0%.

CONCLUSIONS

The study results demonstrate that the VASCADE MVP XL device provides safe and effective percutaneous closure of femoral venous access sites after catheter-based procedures using 16-17F OD sheaths. Compared to standard performance goals from manual compression, the VASCADE MVP XL significantly reduced time to ambulation, hemostasis, discharge eligibility, and overall post-procedure time.