Study to Demonstrate the Safety and Performance of the VASCADE 5F Vascular Closure System (VCS)

Not Applicable

Recruiting

• Conditions: Closure of femoral artery puncture wound; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12611001247965
• Lead Sponsor: Cardiva Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Clinically indicated for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5 Fr introducer sheath

Exclusion Criteria

Key Pre-Operative Exclusion Criteria
1. Active systemic or a cutaneous infection
2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids
3. Ipsilateral femoral arteriotomy within the previous 30 days
4. Planned endovascular procedure within the next 30 days
5. Unilateral or bilateral lower extremity amputation(s)
6. Extreme morbid obesity [Body Max Index (BMI) greater than 45 kg/m2] or underweight (BMI less than 22 kg/m2)
7. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, backwall stick”, etc.)
8. Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary effectiveness endpoint is the time to achieve arterial hemostasis.[Index procedure];The primary safety endpoint is the 30-day rate of combined access site-related major complications.[Index procedure and 30 day Follow-up post procedure]

Secondary Outcome Measures

Name	Time	Method
The secondary effectiveness endpoint is time to ambulation.[Elapsed time between device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site];Time to discharge eligibility[Elapsed time between device removal and when subject is medically able to be discharged based solely on access site assessment.];Time to hospital discharge[Elapsed time between device removal and when subject actually is discharged from the hospital, as recorded on the discharge order.]