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

NCT05335525 | Unknown

• 1 other identifier: T139E4
• Study Type: observational
• Target: 230
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Vascular Closure; Endovascular Procedure; Hemostasis; Peripheral Vascular Disease; Femoral Artery

Keywords

Peripheral Intervention; CFA arteriotomy closure; Common Femoral Artery Access Site; Vascular Closude Device (VCD)

Outcome Measures

Primary Outcomes (2)

• Effectiveness: Successful puncture site haemostasis

  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

  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 Outcomes (6)

• Freedom from any minor complications at the target limb access site

  6 hours post-procedure

• Freedom from any major and minor complications at the target limb access site

  30 days post-procedure

• Time to hemostasis (TTH)

  up to 1 day

• Time to ambulation (TTA)

  up to 30 days

• Quality of Life assessment (EQ-5D)

  30 days post-procedure

Interventions

Closure of the femoral arterial puncture site DEVICE

Patient will undergo a diagnostic or interventional endovascular procedure, compatible with the use of Angio-Seal™ VIP VCD.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject is ≥ 18 years old
• Subject is willing and able to complete the follow-up requirements
• 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)
• Patient undergoing diagnostic or interventional endovascular procedure compatible with the use of Angio-SealTM VIP VCD
• Puncture site located at the femoral artery (i.e., between the inguinal ligament and the bifurcation of the superficial femoral and profunda femoris arteries)
• Angio-SealTM VIP VCD deployed as per instruction for use by a trained operator

You may not qualify if:

• Use of the Angio-SealTM VIP VCD on puncture sites other than the femoral artery
• Repuncture of the femoral artery within 90 days at the same access site
• Lumen diameter of femoral artery \< 4 mm
• Patients with clinically significant peripheral vascular disease at the puncture site (luminal narrowing of \>40% within 5 mm of the puncture site)
• Puncture site at or distal to the bifurcation of the superficial femoral and profunda femoris artery
• Puncture site proximal to the inguinal ligament
• Procedure sheath placed through the superficial femoral artery into the profunda femoris
• Multiple femoral punctures
• Known or suspected posterior femoral wall puncture
• 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
• Any condition that would make use of Angio-SealTM VIP VCD inappropriate (as per IFU and investigators' discretion)

Sponsors & Collaborators

• Terumo Europe N.V.: lead
• Terumo Medical Corporation: collaborator

Study Sites (4)

Hôpital Universitaire Henri Mondor

Créteil, 94000, France

NOT YET RECRUITING

Hôpital Européen Georges-Pompidou (HEGP), Interventional Radiology department

Paris, 75015, France

RECRUITING

Bonifatius Hospital Lingen, Clinic for Vascular Surgery

Lingen, 49808, Germany

RECRUITING

VieCuri Medisch Centrum

Venlo, 5912, Netherlands

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Evelyne Vicca

CONTACT

+32 16 381284; evelyne.vicca@terumo-europe.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: September 30, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1); FR (2)