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OpenTrials
Completed

NCT Number: NCT02948257

VASCADE ANTEGRADE-PVD Post-Market Registry

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.

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Institute of the South, Houma, Louisiana, United States

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About this study

Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiva Medical VASCADE VCS

Device

At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.

Primary outcomes

  1. Time to Hemostasis (TTH)

    Time frame: Procedural, usually within 15 minutes of enrollment

    Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.

  2. Major Access Site Closure-related Complications

    Time frame: Through 30 days +/- 7 days

    Patient incident rate of combined major access site closure-related complications through 30 days

Secondary outcomes

  1. Time to Ambulation (TTA)

    Time frame: Prior to discharge, usually within 24 hours

    Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.

  2. Time to Discharge (TTD)

    Time frame: Through hospital discharge, usually within 24 hours

    Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.

  3. Device Success

    Time frame: Procedural, usually within 15 minutes of enrollment

    Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.

  4. Procedure Success

    Time frame: Through 30 +/- 7 days

    Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.

  5. Minor Access Site Closure-related Complications

    Time frame: Through 30 +/- 7 days

    Patient incident rate of combined minor access site closure-related complications through 30 days

Sponsors and collaborators

Lead sponsor

Cardiva Medical, Inc.

Industry

Registry information

Official study title

Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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