Status:
UNKNOWN
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
Lead Sponsor:
Vivasure Medical Limited
Conditions:
Percutaneous Arteriotomy Closure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The P...
Detailed Description
The study will be designed to be a phased study with an initial enrolment of 25 subjects in phase 1. An interim analysis may be performed after phase 1 and the remainder (up to 65 subjects) may be enr...
Eligibility Criteria
Inclusion
- Over 18 years of age.
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 14 - 22 F sheath.
- General
Exclusion
- Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
- Evidence of systemic bacterial or cutaneous infection, including groin infection.
- Known bleeding diathesis (including sever liver disease), definite or potential coagulopathy, platelet count \< 100,000/µl or patients on long term anticoagulants with an INR greater than 2 at time of procedure or known type II heparin-induced thrombocytopenia.
- Previous groin surgery within the region of the ipsilateral access.
- Severe; claudication or peripheral vascular disease (e.g. Rutherford category 3 or greater or ABI \< 0.5), documented untreated iliac artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of ipsilateral limb.
- Known allergy to any of the materials used in the PerQseal® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
- Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
- Patients that have undergone a percutaneous procedure in the ipsilateral leg, within the previous 30 days.
- Patients that have undergone a percutaneous procedure using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days.
- Evidence of arterial diameter stenosis \> 20% or anterior or circumferential calcification within 20 mm proximal or distal to target arteriotomy site based on pre-procedure CT angiography.
- Females who are pregnant or lactating or in fertile period not taking adequate contraceptives. A pregnancy test may be performed.
- Patients that have a lower extremity amputation from the ipsilateral or contralateral limb.
- Target puncture site is located in a vascular graft.
- Procedural
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04799769
Start Date
March 10 2021
End Date
March 10 2023
Last Update
April 12 2022
Active Locations (5)
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1
SHG-Kliniken Völklingen
Völklingen, Saarland, Germany, D-66333
2
Leipzig University Hospital
Leipzig, Saxony, Germany, 04103
3
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, I323538
4
St. Franziskus-Hospital
Münster, Westphalia, Germany, 48 145