Percutaneous CFA Arteriotomy Closure Clinical Trial
— Frontier-IVOfficial title:
Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER IV Study
| Verified date | January 2023 |
| Source | Vivasure Medical Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | November 19, 2019 |
| Est. primary completion date | November 19, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Kerckhoff Klinik, Bad Nauheim | Bad Nauheim | Hesse |
| Germany | The Charité - Universitätsmedizin | Berlin-Mitte | Berlin |
| Germany | Contilia Heart and Vascular centre | Essen | North Rhine-Westphalia |
| Germany | CardioVasculäres Centrum | Frankfurt am Main | Hesse |
| Germany | Asklepios Klinik St. Georg Medizinische Abteilung | Hamburg | |
| Germany | Uniklinik Köln, Herzzentrum | Köln | North Rhine-Westphalia |
| Germany | Medical Faculty of the University of Leipzig | Leipzig | Saxony |
| Germany | Universitätsmedizin Mainz | Mainz | Rhineland-Palatinate |
| Germany | St Franziskus Hospital | Muenster | North Rhine-Westphalia |
| Ireland | Blackrock Clinic | Blackrock | Dublin |
| Ireland | St James Hospital | Dublin |
| Lead Sponsor | Collaborator |
|---|---|
| Vivasure Medical Limited |
Germany, Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Major Vascular Complications [Safety] | Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2) | up to 1 month post implantation | |
| Secondary | Minor Vascular Complications [Safety] | Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2) | up to 1 month from implantation | |
| 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 | within 24 hours |