VASCADE ANTEGRADE-PVD Post-Market Registry

January 6, 2020 updated by: Cardiva Medical, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North MS Medical Center
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Coastal Surgery Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Texas
      • San Antonio, Texas, United States, 78258
        • San Antonio Endovascular and Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Procedural, usually within 15 minutes of enrollment
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
Through 30 days +/- 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Prior to discharge, usually within 24 hours
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.
Through hospital discharge, usually within 24 hours
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.
Procedural, usually within 15 minutes of enrollment
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.
Through 30 +/- 7 days
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
Through 30 +/- 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiva Medical, Inc.

Investigators

  • Principal Investigator: Mehdi Shishehbor, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

September 18, 2017

Study Completion (Actual)

September 18, 2017

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL 0502-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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