MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Essential Medical, Inc.263 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

263

Conditions

Femoral Arteriotomy Closure

Interventions

MANTA vascular closure deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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) 2. 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 3. Eligible for sheath removal in the catheterization lab 4. Age ≥21 years 5. Understand and sign the study specific written informed consent form 6. Able and willing to fulfill the follow-up requirements 7. 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: 1. Known to be pregnant or lactating 2. Immunocompromised or with pre-existing autoimmune disease 3. Systemic infection or a local infection at or near the access site 4. Significant anemia (hemoglobin \<10 g/DL, hematocrit \<30%) 5. Morbidly obese or cachectic (BMI \>40 kg/m2 or \<20 kg/m2) 6. Known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease 7. Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel 8. Femoral artery puncture in target groin within the prior 14 days 9. Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area 10. Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation 11. Patients who are not mobile and are confined to a wheelchair or bed 12. NYHA class IV heart failure 13. Patients who have already participated in the IDE study 14. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period 15. 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

Locations (19)

San Diego VA Medical Center

San Diego, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: Up to 30 days after procedure

Secondary Outcomes

Technical Success

Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention

Time frame: 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

Time frame: 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

Time frame: Up to 30 days after procedure

Data from ClinicalTrials.gov

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