Safety and Performance Study of Large Hole Vascular Closure Device - France

NCT05323877 | Unknown DMC

• 1 other identifier: P861-00
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 20 patients in 2 centres within France. 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 - 22 F sheaths (arteriotomy up to 26 F).

Conditions

Large Hole Percutaneous Arterial Closure

Keywords

Arterial closure; Percutaneous arterial closure; Large hole arterial closure; Large bore arterial closure

Outcome Measures

Primary Outcomes (1)

• Vascular Access site Safety (Major Compications)

  Major vascular access site complication rate related to the PerQseal® + Closure Device as per VARC-2 definitions

  1-month post implantation (inclusive)

Secondary Outcomes (2)

• Vascular Access Site Safety (Minor Complications)

  1-month post implantation (inclusive)

• Performance

  Up to 5 days post implantation

Study Arms (1)

Investigational Device Arm (PerQseal+)

EXPERIMENTAL

Large hole percutaneous arterial closure device - PerQseal+

Device: Test Device (PerQseal+)

Interventions

Test Device (PerQseal+) DEVICE

Percutaneous arterial closure device

Also known as: PerQseal+

Investigational Device Arm (PerQseal+)

Eligibility Criteria

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

You may qualify if:

• i. Over 18 years of age. ii. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
• iii. Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 14 - 22 F sheath.

You may not qualify if:

• i. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
• ii. Evidence of systemic bacterial or cutaneous infection, including groin infection.
• iii. 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.
• iv. Previous groin surgery within the region of the ipsilateral access. v. 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.
• vi. Known allergy to any of the materials used in the PerQseal® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
• vii. Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
• viii. Patients that have undergone a percutaneous procedure in the ipsilateral leg, within the previous 30 days.
• ix. Patients that have undergone a percutaneous procedure using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days.
• x. 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.
• xi. Females who are pregnant or lactating or in fertile period not taking adequate contraceptives. A pregnancy test may be performed.
• xii. Patients that have a lower extremity amputation from the ipsilateral or contralateral limb.
• xiii. Target puncture site is located in a vascular graft.
• xiv. Arterial access other than common femoral artery obtained for ipsilateral target leg.
• xv. Subject has a tissue tract expected to be greater than 10 cm. xvi. Significant blood loss/transfusion (defined as requiring transfusion of 4 or more units of blood products) during index procedure or within 30 days prior to index procedure.
• xvii. Unstable blood pressure or heart rate, symptoms of shock or systolic blood pressure greater than 160 mmHg (maybe controlled by pacing or pharmacologically eg. vasodilator such as nitrates etc.).

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Officials

• Lionel Leroux, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

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: January 7, 2022
• First Posted: April 12, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share