Clinical trial NCT05335525: Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Official title: Post-market Clinical Investigation of the Angio-Seal™ VIP VCD: A Prospective, Multi-center Observational Study (ANGIO-SEAL CLOSE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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)
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
Collaborators: name: Terumo Medical Corporation
First posted: 2022-04-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 230 enrolled subjects undergoing diagnostic or interventional endovascular procedures in which Angio-SealTM VIP VCD is used

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Effectiveness: Successful puncture site haemostasis
timeFrame: 6 hours post-procedure
measure: Safety: freedom from major complications of the access site limb
timeFrame: 6 hours post-procedure
Secondary outcomes:
measure: Freedom from any minor complications at the target limb access site
timeFrame: 6 hours post-procedure
measure: Freedom from any major and minor complications at the target limb access site
timeFrame: 30 days post-procedure
measure: Time to hemostasis (TTH)
timeFrame: up to 1 day
measure: Time to ambulation (TTA)
timeFrame: up to 30 days
measure: Quality of Life assessment (EQ-5D)
timeFrame: 30 days post-procedure
measure: Angio-SealTM VCD usability
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Universitaire Henri Mondor
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou (HEGP), Interventional Radiology department
city: Lingen
country: Germany
facility: Bonifatius Hospital Lingen, Clinic for Vascular Surgery
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
Study officials:
References: