MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MANTA vascular closure device	MANTA vascular closure device	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Major Complications, Within 30 Days of Procedure	Up to 30 days after procedure	IDE Protocol-Defined Major Complications analyzed on a per-patient basis
Time to Hemostasis	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 Outcome Measures

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

Locations (19): Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
San Diego VA Medical Center
🇺🇸
San Diego, California, United States
St. Vincent Heart Center
🇺🇸
Indianapolis, Indiana, United States
Houston Methodist
🇺🇸
Houston, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Evanston Hospital
🇺🇸
Evanston, Illinois, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Avera Heart Hospital
🇺🇸
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Hospital
🇺🇸
Kingsport, Tennessee, United States
St. Luke's Hospital - Texas Heart
🇺🇸
Houston, Texas, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
CAMC Memorial Hospital
🇺🇸
Charleston, West Virginia, United States
Lankenau Heart Group
🇺🇸
Wynnewood, Pennsylvania, United States
Henry Ford
🇺🇸
Detroit, Michigan, United States
St. Luke Hospital (Mid America Heart)
🇺🇸
Kansas City, Missouri, United States