Conformite Europeenne (CE) Mark Study to Demonstrate the Safety and Performance of the Champion Vascular Closure System (VCS)

Not Applicable

Completed

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

• Registration Number: ACTRN12610000831088
• Lead Sponsor: Cardiva Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Clinically indicated for an diagnostic or interventional endovascular procedure anticipated to employ common femoral artery access using a modified Seldinger technique and a 6F or 7F introducer sheath

Exclusion Criteria

Key PRE-OPERATIVE EXCLUSION CRITERIA
1.Septicemia or a cutaneous/subcutaneous groin infection
2.Ipsilateral femoral arteriotomy within the previous 30 days
3.Planned arterial access at the same site within the next 90 days
4.Extreme morbid obesity (Body mass index (BMI) greater than 45 kg/m2) or underweight (BMI less than 22 kg/m2)
5.Femoral artery diameter less than 6 mm
6.Difficulty achieving arterial access and/or inserting the introducer sheath at the onset of the procedure (e.g., multiple stick attempts)
7.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 efficacy endpoint is the time to achieve arterial hemostasis.[Index procedure and 30 day Follow-up post procedure];The primary safety endpoint is the rate of major complications and the secondary safety endpoint is the rate of minor complications.[Index procedure and 30 day Follow-up post procedure]

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoint is time to ambulation[Ability of the subject to walk 20 feet without evidence of arterial re-bleeding from the access site. The time to ambulation will be measured in hours from the time the Champion catheter is removed until the subject is able to ambulate.];Time to discharge.[The time to discharge is measured from the time the Champion catheter is removed to hospital discharge.];The time to eligibility for hospital discharge[The time to eligibility for hospital discharge is measured from the time the Champion catheter is removed to the time, in the judgment of the investigator, that the subject was eligible for hospital discharge based on institution?s standard of care.]