Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)

April 18, 2023 updated by: Terumo Europe N.V.

Post-market Clinical Investigation of the Angio-Seal™ VIP VCD: A Prospective, Multi-center Observational Study (ANGIO-SEAL CLOSE)

The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The proposed Post-Market Clinical Follow-up study is a prospective, multi-Center, observational study, aiming to further demonstrate the safety and effectiveness of the Angio-SealTM VIP VCD in achieving hemostasis of femoral artery access site in real-world subjects undergoing percutaneous endovascular procedures. 230 patients will be enrolled at up to 6 sites in Europe. Follow-ups are scheduled at 30 days (+7 days) by hospital visit or telephone call.

The sponsor shall provide training and the necessary guidelines to assist each investigation site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality, validation & consistency, edit checks will be designed during database development. Data Management team and the study monitors will be responsible to review the data and raise queries in the eCRF. Data cleaning will be done in regular intervals specified in DMP. The final clean standardised datasets will be available prior to database lock for data analysis. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.

The study will be monitored at all stages of its development by study monitors appointed by the sponsor. Study monitors are designated as Sponsor representatives and are assigned to oversee the conduct and progress of the study at each site in accordance with the Monitoring Plan established for this clinical investigation.

Study Type

Observational

Enrollment (Anticipated)

230

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

  • France
      • Créteil, France, 94000
        • Not yet recruiting
        • Hôpital Universitaire Henri Mondor
        • Principal Investigator:
          • Hicham Kobeiter
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges-Pompidou (HEGP), Interventional Radiology department
        • Principal Investigator:
          • Marc Sapoval
        • Contact:
  • Germany
      • Lingen, Germany, 49808
        • Recruiting
        • Bonifatius Hospital Lingen, Clinic for Vascular Surgery
        • Contact:
        • Principal Investigator:
          • Jörg Teßarek
  • Netherlands
      • Venlo, Netherlands, 5912
        • Recruiting
        • VieCuri Medisch Centrum
        • Principal Investigator:
          • Carsten Arnoldussen
        • Contact:
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

230 enrolled subjects undergoing diagnostic or interventional endovascular procedures in which Angio-SealTM VIP VCD is used

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years old
  2. Subject is willing and able to complete the follow-up requirements
  3. Subject has the mental capacity (i.e., does not require the use of a Legally Authorized Representative) to sign the study Informed Consent Form (ICF)
  4. Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of Angio-SealTM VIP VCD
  5. Puncture site located at the femoral artery (i.e., between the inguinal ligament and the bifurcation of the superficial femoral and profunda femoris arteries)
  6. Angio-SealTM VIP VCD deployed as per instruction for use by a trained operator

Exclusion Criteria:

  • Use of the Angio-SealTM VIP VCD on puncture sites other than the femoral artery

    1. Repuncture of the femoral artery within 90 days at the same access site
    2. Lumen diameter of femoral artery < 4 mm
    3. Patients with clinically significant peripheral vascular disease at the puncture site (luminal narrowing of >40% within 5 mm of the puncture site)
    4. Puncture site at or distal to the bifurcation of the superficial femoral and profunda femoris artery
    5. Puncture site proximal to the inguinal ligament
    6. Procedure sheath placed through the superficial femoral artery into the profunda femoris
    7. Multiple femoral punctures
    8. Known or suspected posterior femoral wall puncture
    9. Use of > 8F primary introducer sheaths or devices for an 8Fr Angio-SealTM VIP, or use of a >6Fr primary introducer sheaths or devices for a 6Fr Angio-SealTM VIP
    10. Any condition that would make use of Angio-SealTM VIP VCD inappropriate (as per IFU and investigators' discretion)

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness: Successful puncture site haemostasis
Time Frame: 6 hours post-procedure
Cessation of arterial bleeding (excluding oozing) achieved in the interventional lab in subjects not requiring adjunctive intervention at the access site, including manual compression.
6 hours post-procedure
Safety: freedom from major complications of the access site limb
Time Frame: 6 hours post-procedure

Major complications attributable to Angio-Seal TM VIP VCD are defined as:

  • Access site-related bleeding (BARC type 2, 3 or 5, following Angio-SealTM VIP VCD deployment, as per Bleeding Academic Research Consortium (BARC) classification)
  • Femoral puncture site haematoma >6
  • Pseudoaneurysms requiring intervention
  • Femoral access site arteriovenous fistulas
  • Access site infection requiring hospitalization
  • Embolism (due to Anchor fracture)
  • Thrombosis at puncture site (due to collagen disposition into the artery)
  • Allergic Reaction to Angio-SealTM VIP components
  • Foreign body reaction
  • Inflammation and Edema
6 hours post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from any minor complications at the target limb access site
Time Frame: 6 hours post-procedure

Minor complications are defined as:

  • Femoral puncture site Hematoma <6cm
  • Access site Infection not requiring hospitalization
  • Pseudoaneurysm not requiring intervention
  • Vasovagal response
6 hours post-procedure
Freedom from any major and minor complications at the target limb access site
Time Frame: 30 days post-procedure
30 days post-procedure
Time to hemostasis (TTH)
Time Frame: up to 1 day
TTH is defined as time from completion of device deployment up to first observed arterial bleeding cessation (excluding oozing at access site) in subjects not requiring adjunctive intervention in the interventional lab
up to 1 day
Time to ambulation (TTA)
Time Frame: up to 30 days
TTA is defined as the time from device deployment up to the moment when the patient is able to ambulate
up to 30 days
Quality of Life assessment (EQ-5D)
Time Frame: 30 days post-procedure
30 days post-procedure
Angio-SealTM VCD usability
Time Frame: up to 1 day
up to 1 day

Collaborators and Investigators

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

Sponsor

Terumo Europe N.V.

Collaborators

Terumo Medical Corporation

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)

September 30, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T139E4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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