Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femoral Arteriotomy Closure
- Sponsor
- Essential Medical, Inc.
- Enrollment
- 263
- Locations
- 19
- Primary Endpoint
- Number of Patients With Major Complications, Within 30 Days of Procedure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Patients With Major Complications, Within 30 Days of Procedure
Time Frame: Up to 30 days after procedure
IDE Protocol-Defined Major Complications analyzed on a per-patient basis
Time to Hemostasis
Time Frame: During access site closure, usually within an hour of starting the procedure.
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).
Secondary Outcomes
- Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure(Up to 30 days after procedure)
- Technical Success(Within 6 hours after deployment of the MANTA device)
- Number of Patients With Minor Complications, Within 30 Days of Procedure(Up to 30 days after procedure)