MANTA Ultrasound Closure Study

NCT05142566 | Terminated Results DMC FDA Device

• 1 other identifier: ST-3370
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 6

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.

Conditions

Femoral Arteriotomy Closure

Keywords

MANTA; Arterial Closure Device; Ultrasound Closure; Large Bore Closure Device

Outcome Measures

Primary Outcomes (1)

• Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication

  adapted from VARC-2 Criteria

  within 30 days

Secondary Outcomes (7)

• Time to Hemostasis

  During the procedure

• Number of Patients With Technical Success

  within 30 days

• Number of Subjects With Ambulation Success

  During procedure admission

• Time to Ambulation

  During procedure admission

• Treatment Success

  within 30 days

Study Arms (1)

Ultrasound Closure

EXPERIMENTAL

Open label, single arm study using ultrasound guidance during MANTA device deployment.

Device: MANTA Vascular Closure Device

Interventions

MANTA Vascular Closure Device DEVICE

Evaluate the safety of ultrasound guided deployment of MANTA VCD.

Ultrasound Closure

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essential Medical, Inc.: lead
• Teleflex: collaborator

Study Sites (6)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Baylor Scott & White

Round Rock, Texas, 78665, United States

Location

Sentara Northern Virginia Medical Center

Woodbridge, Virginia, 22191, United States

Location

Vancouver General Health

Vancouver, British Columbia, Canada

Location

Limitations and Caveats

The Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study (ST-3370) was terminated early primarily for business reasons. The sponsor recognized that the conditions for widespread adoption of ultrasound-based MANTA deployment do not presently exist. As a result of this finding and the likelihood that the study would not provide sufficient data to support a future labeling change, the sponsor decided to terminate the study.

Results Point of Contact

• Title: Darra Bigelow, Sr. Manager, Clinical Operations
• Organization: Essential Medical LLC (a subsidary of Teleflex, Inc.)

darra.bigelow@teleflex.com

610-331-7299

Study Officials

• David Wood

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

• Vijay Iyer

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 2, 2021
• Study Start: August 9, 2022
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5); CA (1)