Status:
UNKNOWN
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Lead Sponsor:
Terumo Europe N.V.
Collaborating Sponsors:
Terumo Medical Corporation
Conditions:
Vascular Closure
Endovascular Procedure
Eligibility:
All Genders
18+ years
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 set...
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 achievi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05335525
Start Date
September 30 2022
End Date
May 1 2023
Last Update
April 20 2023
Active Locations (4)
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1
Hôpital Universitaire Henri Mondor
Créteil, France, 94000
2
Hôpital Européen Georges-Pompidou (HEGP), Interventional Radiology department
Paris, France, 75015
3
Bonifatius Hospital Lingen, Clinic for Vascular Surgery
Lingen, Germany, 49808
4
VieCuri Medisch Centrum
Venlo, Netherlands, 5912