Percutaneous CFA Arteriotomy Closure
Conditions
Keywords
Percutaneous vascular closure device, Large hole closure device, Arteriotomy closure, Vascular closure device
Brief summary
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
Detailed description
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® in 75 patients in approximately 10 European investigational sites. The study shall not be blinded prior to, during or post the procedure. All patients undergoing an endovascular procedure requiring an arteriotomy created by 12 to 20 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. All subjects shall have an immediately post procedure, \ 24 hour, 1 and 3 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee on a continuous basis.
Interventions
DEVICEPerQseal®
Large hole closure system
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
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 12 - 20 F sheath.
Exclusion criteria
* Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than six months. * Evidence of systemic bacterial or cutaneous infection, including groin infection. * Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/μl or patients on long term anticoagulants with an INR greater than 1.2 at time of procedure or known type II heparin-induced thrombocytopenia. * 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®. * 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. * Arterial access other than common femoral artery obtained for ipsilateral target leg. * Subject has a tissue tract expected to be greater than 10 cm. * Use of thrombolytic agents within 24 hours prior to or during the endovascular procedure which causes fibrinogen \< 100 mg/dl. * 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. * Activated clotting time (ACT) \> 350 seconds immediately prior to sheath removal or if ACT measurements are expected to be \> 350 seconds for more than 24 hours after index procedure. * Target puncture site is located in a vascular graft. * Target arteriotomy in the profunda femoris or superficial femoral artery or is in common femoral artery, but within 10 mm proximal of the bifurcation of the Superficial Femoral /Profunda Femoris artery. * PerQseal® Introducer-sheath to ipsilateral femoral artery diameter ratio is greater than or equal to 1.05. * Subjects with an acute haematoma of any size, arteriovenous fistula or pseudoaneurysm at the target access site; or angiographic evidence of arterial laceration or dissection within the external iliac or femoral artery before the use of the PerQseal® closure device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Vascular Complications [Safety] | up to 1 month post implantation | Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor Vascular Complications [Safety] | up to 1 month from implantation | Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2) |
| Study Device Technical Success Rate [Performance] | within 24 hours | Percentage of closures (Limbs) with Technical Success, for the PerQseal® closure device, not requiring alternative therapy to achieve haemostasis |
Countries
Germany, Ireland
Participant flow
Recruitment details
Patients from each of the participating centres undergoing an endovascular interventional procedure requiring a percutaneous common femoral arterial access using sheath sizes in the range of 12 to 20 F were screened against the inclusion/exclusion criteria for eligibility. If a patient met the requirements of the clinical investigation, they were invited to participate, given patient information relative to the study and if willing to participate were asked to sign informed consent.
Pre-assignment details
Subjects with bilateral percutaneous access in both common femoral arteries, where both arteries met all eligibility criteria, were closed bilaterally with the Investigational device, at the discretion of the investigator. If a test device was used on both ipsilateral and contralateral femoral arteries, then each closure (i.e. each limb) was treated as an independent closure.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Device To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths.
PerQseal®: Large hole closure system | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Investigational Device | — |
|---|---|---|
| Age, Continuous | 78.7 years STANDARD_DEVIATION 8 | — |
| Co-morbidity Bleeding diatheses | 2 Participants | — |
| Co-morbidity Claudication | 1 Participants | — |
| Co-morbidity Clinically significant peripheral vascular disease | 2 Participants | — |
| Co-morbidity Diabetes | 22 Participants | — |
| Co-morbidity Hypertention | 65 Participants | — |
| Co-morbidity Previous peripheral vascular surgery involving the aorta or lower extremities | 4 Participants | — |
| Co-morbidity Severe acute non-cardiac systemic disease, autoimmune disease or terminal illness | 0 Participants | — |
| Height | 170.1 cm STANDARD_DEVIATION 9.4 | — |
| Primary Procedure type EVAR | 30 Participants | — |
| Primary Procedure type TAVR | 41 Participants | — |
| Primary Procedure type TEVAR | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 70 participants | — |
| Region of Enrollment Ireland | 5 participants | — |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 46 Participants | — |
| Weight | 80.8 kg STANDARD_DEVIATION 15.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 75 |
| other Total, other adverse events | 5 / 75 |
| serious Total, serious adverse events | 21 / 75 |
Outcome results
Primary
Major Vascular Complications [Safety]
Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)
Time frame: up to 1 month post implantation
Population: All enrolled subjects with any major device related event. Includes all subjects through the last assessment prior to or at 1-month post implantation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Device | Major Vascular Complications [Safety] | 0 Participants |
Comparison: The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure.p-value: <0.0001Wilson's exact test
Secondary
Minor Vascular Complications [Safety]
Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)
Time frame: up to 1 month from implantation
Population: All subjects with any minor device related event. Includes all subjects through the last assessment prior to or at 1-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Device | Minor Vascular Complications [Safety] | All enrolled subjects | 5 Participants |
| Investigational Device | Minor Vascular Complications [Safety] | Subjects still enrolled at 1-month with follow-up | 3 Participants |
Secondary
Study Device Technical Success Rate [Performance]
Percentage of closures (Limbs) with Technical Success, for the PerQseal® closure device, not requiring alternative therapy to achieve haemostasis
Time frame: within 24 hours
Population: Technical success analysis included all closures that received the investigational device (79)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Investigational Device | Study Device Technical Success Rate [Performance] | 75 Limbs |