MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Study Overview
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Brief Summary
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Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.

Detailed Description
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The MANTA device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Official Title
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Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device

Conditions
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Femoral Arteriotomy Closure

Intervention / Treatment
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* Device: MANTA vascular closure device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use) Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA Eligible for sheath removal in the catheterization lab Age ≥21 years Understand and sign the study specific written informed consent form Able and willing to fulfill the follow-up requirements In the investigator's opinion, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial Exclusion Criteria: Known to be pregnant or lactating Immunocompromised or with pre-existing autoimmune disease Systemic infection or a local infection at or near the access site Significant anemia (hemoglobin <10 g/DL, hematocrit <30%) Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2) Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel Femoral artery puncture in target groin within the prior 14 days Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation Patients who are not mobile and are confined to a wheelchair or bed NYHA class IV heart failure Patients who have already participated in the IDE study Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MANTA vascular closure device<br>Open label, single arm study using the MANTA device, developed by Essential Medical, Inc. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices. | Device: MANTA vascular closure device<br>* The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.<br>* Other names: MANTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma). | During access site closure, usually within an hour of starting the procedure. | 
| Number of Patients With Major Complications, Within 30 Days of Procedure | IDE Protocol-Defined Major Complications analyzed on a per-patient basis | Up to 30 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention | Within 6 hours after deployment of the MANTA device | 
| Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure | Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis | Up to 30 days after procedure | 
| Number of Patients With Minor Complications, Within 30 Days of Procedure | Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis | Up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MANTA, Arterial Closure Device, Large Bore Closure Device