MANTA Ultrasound Closure Study (MANTA ULTRA)

Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study

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.

Study Overview

• Status: Terminated
• Conditions: Femoral Arteriotomy Closure
• Intervention / Treatment: Device: MANTA Vascular Closure Device

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Health
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
  • Texas
    • Round Rock, Texas, United States, 78665
      • Baylor Scott & White
  • Virginia
    • Woodbridge, Virginia, United States, 22191
      • Sentara Northern Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound Closure; Open label, single arm study using ultrasound guidance during MANTA device deployment.	Device: MANTA Vascular Closure Device; Evaluate the safety of ultrasound guided deployment of MANTA VCD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication	adapted from VARC-2 Criteria	within 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Essential Medical, Inc.
• Collaborators: Teleflex
• Investigators: Principal Investigator: David Wood, Vancouver General Hospital; Principal Investigator: Vijay Iyer, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): January 11, 2023
• Study Completion (Actual): January 11, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MANTA; Arterial Closure Device; Large Bore Closure Device; Ultrasound Closure
• Other Study ID Numbers: ST-3370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data obtained will be used, without mentioning Subject PHI, to assess the results of the research, and the data could be used in the future with regard to this study or other studies. The data can be passed on to the health authorities for the purposes of registering the medical device.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes