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

Femoral Artery closure using the Cardiva Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000831088

Enrollment

Registered

2010-10-05

Start date

2010-07-26

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Cardiva VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The Cardiva VCS is intended to seal or close the femoral arterial access sites while reducing time to hemostasis (stop the bleeding process) and time to ambulation (when a person can walk) in subjects who have undergone diagnostic or interventional endovascular procedures.

Interventions

The Cardiva Champion VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The Champion VCS is intended to seal a femoral arterial access site at the end of any procedure that uses a 6French or 7 French cathether to access the femoral artery. This is a one time use device. The procedure of deploying the collagen patch takes less than 3-5 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results