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

Terumo Europe N.V.230 enrolled

Overview

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.

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

230

Conditions

Vascular Closure Endovascular Procedure Hemostasis Peripheral Vascular Disease Femoral Artery

Interventions

Closure of the femoral arterial puncture siteDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Hôpital Universitaire Henri Mondor

Créteil, France

NOT_YET_RECRUITING

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

Paris, France

RECRUITING

Bonifatius Hospital Lingen, Clinic for Vascular Surgery

Lingen, Germany

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 6 hours post-procedure

Secondary Outcomes

Freedom from any minor complications at the target limb access site

Minor complications are defined as: * Femoral puncture site Hematoma \<6cm * Access site Infection not requiring hospitalization * Pseudoaneurysm not requiring intervention * Vasovagal response

Time frame: 6 hours post-procedure

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

Time frame: 30 days post-procedure

Time to hemostasis (TTH)

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

Time frame: up to 1 day

Central Contacts

Evelyne Vicca

CONTACT

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

Data from ClinicalTrials.gov

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