Percutaneous Arteriotomy Closure
Conditions
Keywords
Arterial Closure, percutaneous arterial closure, large hole arterial closure, large bore arterial closure
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).
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 enrolled as part of phase 2. The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 14 to 22 F sheaths, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a 'Subject Number'. The closure will be percutaneous. An optional adjunctive endovascular balloon may be used to control bleeding. All safety data from the study will be assessed by the Data Safety Monitoring Committee on a continuous basis. The Purpose of the Study is to assess safety and performance of the PerQseal® + Closure Device when used with the L PerQseal® Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 14 to 22 F sheaths.
Interventions
DEVICEPercutaneous arterial closure device
Large hole percutaneous arterial closure device
Sponsors
Vivasure Medical Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® +
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety | 1-month post implantation (inclusive) | Major vascular access site complication rate related to the PerQseal® + Closure Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety | 1-month post implantation (inclusive) | Minor vascular access site complication rate related to the PerQseal® + Closure Device |
| Performance | Up to 5 days post implantation | Technical success rate for the PerQseal® + Closure Device |
Countries
Germany, Netherlands
Contacts
Primary ContactChris Martin, Dr
Outcome results
None listed