MANTA Ultrasound Closure Study

Not Applicable

Terminated

Conditions: Femoral Arteriotomy Closure

Interventions: Device: MANTA Vascular Closure Device

Registration Number: NCT05142566

Lead Sponsor: Essential Medical, Inc.

Brief Summary: Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.

Detailed Description: The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.

This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach
Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD
Understand and sign the study specific written informed consent form and PHI authorization
Able and willing to fulfill the follow-up requirements

Exclusion Criteria

Patients known to be pregnant or lactating
Patients who have a systemic infection or a local infection at or near the access site
Patients with significant anemia (hemoglobin ≤10 g/DL)
Patients who are morbidly obese or cachectic (BMI >40 or <20kg/m2)
Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
Patients with allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
Patients with a femoral artery puncture in target groin within the prior 30 days, prior vascular closure device placement in the target common femoral artery within 3 months, or any prior target femoral artery access-related complication
Patients who have undergone use of an intra-aortic balloon pump (IABP) through the arterial access site within 30 days prior to the baseline evaluation.
Patients who have a Common Femoral Artery (CFA) with visible calcium and/or tortuosity, as determined by baseline CTA, precluding safe access and likely to interact with large bore access site arteriotomy, determined by investigator.
Patients with 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 in whom oral anticoagulation therapy cannot be stopped for the peri procedural period or patients with INR >1.8 at the time of the procedure
Patients who are unable to ambulate at least 6 meters without assistance at baseline
Patients with renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
Patients with existing nerve damage in the ipsilateral leg
Patients with a further planned endovascular procedure within the next 30 days
Patients who have already participated in this IDE study
Patients who are currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period or patient currently participating in another clinical study likely to influence hemostasis and vascular complications
Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
Patients who have a common femoral artery <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a vessel diameter <5mm in diameter for the 14F MANTA VCD or <6 mm in diameter for the 18F MANTA VCD, or > 50% diameter femoral or iliac artery stenosis
Patients in whom, during initial access of the artery, arteriotomy and surrounding anatomy cannot be visualized and identified clearly under U/S imaging and/or if the vertical depth from the surface of the skin to target area of the common femoral artery measures greater than 6cm

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Closure	MANTA Vascular Closure Device	Open label, single arm study using ultrasound guidance during MANTA device deployment.

Primary Outcome Measures

Name	Time	Method
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication	within 30 days	adapted from VARC-2 Criteria

Secondary Outcome Measures

Name	Time	Method
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication	within 30 days	adapted from VARC-2 Criteria
Treatment Success	within 30 days	Time to Hemostasis ≤10 minutes and no VACR-2 Major complications
Procedure Time	During the procedure	Elapsed time from initial skin break to time when the post-deployment angiogram is completed.
Time to Hemostasis	During the procedure	The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.
Number of Patients With Technical Success	within 30 days	Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.
Number of Subjects With Ambulation Success	During procedure admission	If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.
Time to Ambulation	During procedure admission	The elapsed time between VCD deployment and when ambulation is achieved.

Trial Locations

Locations (6): Vancouver General Health
🇨🇦
Vancouver, British Columbia, Canada
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Henry Ford
🇺🇸
Detroit, Michigan, United States
University of Buffalo
🇺🇸
Buffalo, New York, United States
Baylor Scott & White
🇺🇸
Round Rock, Texas, United States
Sentara Northern Virginia Medical Center
🇺🇸
Woodbridge, Virginia, United States