Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study

NCT04799769 | Unknown DMC

• 1 other identifier: P802-00
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 5

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 PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).

Conditions

Percutaneous Arteriotomy Closure

Keywords

Arterial Closure; percutaneous arterial closure; large hole arterial closure; large bore arterial closure

Outcome Measures

Primary Outcomes (1)

• Primary Safety

  Major vascular access site complication rate related to the PerQseal® + Closure Device

  1-month post implantation (inclusive)

Secondary Outcomes (2)

• Secondary Safety

  1-month post implantation (inclusive)

• Performance

  Up to 5 days post implantation

Study Arms (1)

Test Device

EXPERIMENTAL

Investigational Device Arm

Device: Percutaneous arterial closure device

Interventions

Percutaneous arterial closure device DEVICE

Large hole percutaneous arterial closure device

Test Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Arterial access other than common femoral artery obtained for ipsilateral target leg.
• Subject has a tissue tract expected to be greater than 10 cm.

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (5)

SHG-Kliniken Völklingen

Völklingen, Saarland, D-66333, Germany

RECRUITING

Leipzig University Hospital

Leipzig, Saxony, 04103, Germany

RECRUITING

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, I323538, Germany

RECRUITING

St. Franziskus-Hospital

Münster, Westphalia, 48 145, Germany

RECRUITING

Erasmus Hospital

Rotterdam, South Holland, 3015, Netherlands

RECRUITING

Central Study Contacts

Chris Martin, Dr

CONTACT

+353 91 395 440; chris.martin@vsuremed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® +

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 10, 2021
• Primary Completion: January 10, 2023
• Study Completion: March 10, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DE (4)