AMBULATE EXPAND

A Multi-Center, Prospective, Single Arm, Pivotal Trial to Evaluate the Safety and Efficacy of the VASCADE MVP® XL Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-Based Interventions Performed Utilizing 16-17F Outer Diameter (OD) Sheaths

Objective

The primary objective is to establish the safety and efficacy of the VASCADE MVP XL Study Device when compared to performance goals (PG) and clinical acceptance criteria (CAC) for closing percutaneous femoral venous access sites at the completion of catheter-based procedures utilizing 16-17F OD procedural sheaths.

Eligibility

1. 18 to 80 years of age (inclusive)
2. Capable and willing to give informed consent
3. Planned non-emergent catheter-based procedure via:
   1. Study Limb (Required): The common femoral vein using one 16-17F* OD introducer sheath
      1. *Minimum 10F ID
   2. Non-Study Limb (optional): The common femoral vein of the Non-Study Limb using up to three (3) 5-12F ID (max 15F OD) introducer sheaths
4. Able and willing to complete a 30 day +/- 7 days follow-up visit