The AMBULATE EXPAND Trial: VASCADE MVP XL for Femoral Venous Access Sites, 16-17F OD

Pre-Operative Inclusion Criteria

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 (*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 contact

Pre-Operative Exclusion Criteria

1. Currently involved in any other investigational clinical trial that may interfere with the outcomes of this study, in the opinion of the Investigator
2. Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids
3. Known history of bleeding diathesis, bleeding problems following medical procedures, or coagulopathy
4. Known baseline hemoglobin \< 10 g/dl, hematocrit \< 30%, platelet count \< 100,000 cells/mm3
5. Severe co-existing morbidities, with a life expectancy of less than 12 months in the opinion of the Investigator
6. Known history of deep vein thrombosis or pulmonary embolism in the last 12 months
7. Known allergy/adverse reaction to bovine derivatives
8. Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin
9. Unable to ambulate at least 20 ft at baseline
10. Pregnant (known or suspected) or lactating
11. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2)
12. Known planned procedures or known concomitant condition(s) that may extend ambulation attempts beyond 2-3 hours, and/or hospitalization time (e.g., staged procedure, serious co-morbidity), in the opinion of the Investigator

13. Femoral vessel closure in either limb with any of the following conditions:

    1. Planned femoral access in the next 60 days to reflect the device re-access period
    2. Any residual hematoma, significant bruising, or known associated vascular complications
    3. Use of an intra-vascular closure device within the previous 90 days
    4. Access within \< 10 days
14. Currently known implanted vascular grafts/stents at the access site that would interfere with the planned closure procedure, in the opinion of the Investigator

Intra-Operative Exclusion Criteria

1. Administration of low molecular weight heparin (LMWH) within 8 hours before or planned after the procedure

2. Subject may be ineligible to ambulate per protocol for any reason, for example:

a. Any procedural complications, medical conditions (e.g., extended diuresis required), or issues with Non-Study Access Site closure that may extend recovery, ambulation and discharge times

b. The subject should not attempt ambulation according to the protocol requirements for any reason, in the opinion of the Investigator

3. Any attempted femoral arterial access in either limb during the procedure

4. The Investigator deems that a different method should be used to achieve hemostasis of the Study Access Site than stipulated per protocol (e.g., manual compression)

5. Disease state or other source of interference that would interfere with the use of the device, in the opinion of the Investigator (e.g., vascular grafts or surgery at the target vessel puncture site)

6. The following are exclusions for ALL access sites immediately prior to enrollment unless otherwise noted:

a. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, unintentional vessel stick with hematoma, "back wall stick") in any of the vessel punctures

b. Access site configurations and procedure sheath size outside of the protocol range:

i. Study Limb (required) - MVP XL Study Device:

1. OD: \< 16F or > 17F venous or
2. ID: \< 10F or
3. More than one access site in the Study Limb

ii. Non-Study Limb (optional) - VASCADE Family Commercial Device:

1. OD: > 15F or
2. ID: \< 5F or > 12F venous or
3. More than 3 access sites in the Non-Study Limb or

4. Non-Study Access Site(s) are in the same limb as Study Limb

   c. Vessel access site location is noted to be "high" or not at the common femoral vessel (above the inguinal ligament, cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein)

   d. Intra-procedural bleeding around sheath, forming hematoma, and/or suspected vascular complications

   e. Length of the tissue tract, the distance between the anterior vessel wall and skin, is estimated to be less than 2.5 cm

   f. Femoral vessel diameter less than 6 mm at access site

7. The Non-Study Access Site(s) were not closed successfully with VASCADE commercial device(s) with final hemostasis confirmed prior to Study Access Site closure