Study to Demonstrate the Safety and Efficacy of the CARDIVA VASCADE Vascular Closure System (VCS) versus Manual Compression

Femoral Artery closure using the Cardiva VASCADE Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation and hospital discharge versus manual compression in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 6 Fr or 7 Fr procedural sheaths

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001248954

Enrollment

420

Registered

2011-12-06

Start date

2011-09-13

Completion date

2012-06-06

Last updated

2026-03-30

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 VASCADE VCS consists of a sterile disposable catheter containing a deployable extravascular collagen path and a clip. The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE Vascular Closure System (VCS) in sealing femoral access sites and providing reduced times to hemostasis, time to ambulation, and time to discharge eligibility compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths.

Interventions

The Cardiva VASCADE VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The VASCADE VCS is intended to seal a femoral arterial access site at the end of any procedure that uses a 6 or 7 French introducer sheath 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

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Clinically indicated for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 Fr or 7 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, "back“wall stick”, etc.) 8. Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site

Outcome results