Post-market Clinical Investigation of the Angio-Sealâ„¢ VIP VCD (ANGIO-SEAL CLOSE) (NCT05335525) | Clinical Trial Compass
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Post-market Clinical Investigation of the Angio-Sealâ„¢ VIP VCD (ANGIO-SEAL CLOSE)
France, Germany, Netherlands230 participantsStarted 2022-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Effectiveness: Successful puncture site haemostasis
Timeframe: 6 hours post-procedure
2
Safety: freedom from major complications of the access site limb