N/A
N=52
VASCADE ANTEGRADE-PVD Post-Market Registry
Surgical Wound
Bottom Line
View on ClinicalTrials.gov: NCT02948257 ↗Enrolled (actual)
52
Serious AEs
3.9%
Results posted
Jan 2020
Primary outcome: Primary: Time to Hemostasis (TTH) — 5.87 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cardiva Medical VASCADE VCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiva Medical, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis (TTH) |
5.87 | — |
| PRIMARY Major Access Site Closure-related Complications |
1 | — |
| SECONDARY Time to Ambulation (TTA) |
4.48 | — |
| SECONDARY Time to Discharge (TTD) |
5.97 | — |
| SECONDARY Device Success |
51 | — |
| SECONDARY Procedure Success |
50 | — |
| SECONDARY Minor Access Site Closure-related Complications |
51 | — |
Summary
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
Eligibility Criteria
Inclusion Criteria
- Acceptable candidate for post-procedural manual compression
- Able to ambulate at least 20 feet, with or without assistance
Exclusion Criteria
- Active systemic or cutaneous infection or inflammation
- Ipsilateral femoral arteriotomy with any of the following conditions: a) access within < or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within < or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
- Previous vascular grafts or surgery at the target vessel access site
- Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
- Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
- Femoral arterial diameter < 6 mm at access site
- Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
- Length of tissue tract, the distance between the anterior arterial wall and skin, is < 2.5 cm.
Data sourced from ClinicalTrials.gov (NCT02948257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.