NCT05142566: MANTA ULTRA

MANTA Ultrasound Closure Study

Terminated NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing MANTA Vascular Closure Device in Femoral Arteriotomy Closure in 17 participants. Terminated before completion.

Timeline

9 August 2022

Primary endpoint
11 January 2023

11 January 2023

Quick facts

Lead sponsor	Essential Medical, Inc.
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	9 August 2022
Primary completion	11 January 2023
Estimated completion	11 January 2023
Sites	6 locations across Canada, United States

Drugs / interventions tested

• MANTA Vascular Closure Device

Conditions studied

• Femoral Arteriotomy Closure — all drugs for Femoral Arteriotomy Closure →

Sponsor

Essential Medical, Inc.

Who can join

21 and older, any sex, with Femoral Arteriotomy Closure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication Primary · within 30 days

adapted from VARC-2 Criteria

Group	Value	95% CI
Ultrasound Closure	0

Time to Hemostasis Secondary · During the procedure

The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.

Group	Value	95% CI
Ultrasound Closure	.42	0.00 – 9.87

Number of Patients With Technical Success Secondary · within 30 days

Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.

Group	Value	95% CI
Ultrasound Closure	17

Number of Subjects With Ambulation Success Secondary · 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.

Group	Value	95% CI
Ultrasound Closure	17

Time to Ambulation Secondary · During procedure admission

The elapsed time between VCD deployment and when ambulation is achieved.

Group	Value	95% CI
Ultrasound Closure	8.93	4.21 – 119.05

Treatment Success Secondary · within 30 days

Time to Hemostasis ≤10 minutes and no VACR-2 Major complications

Group	Value	95% CI
Ultrasound Closure	17

Procedure Time Secondary · During the procedure

Elapsed time from initial skin break to time when the post-deployment angiogram is completed.

Group	Value	95% CI
Ultrasound Closure	0.75	0.61 – 1.62

Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication Secondary · within 30 days

adapted from VARC-2 Criteria

Group	Value	95% CI
Ultrasound Closure	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Index procedure up to 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ultrasound Closure

Serious: 2/17 (12%)

Deaths: 0/17

Serious adverse events (4 terms)

Reaction	System	Ultrasound Closure
Transient Ischemic Attack (TIA)	Nervous system disorders	—
Arrhythmia	Cardiac disorders	—
Anemia	Blood and lymphatic system disorders	—
Systemic Infection	Infections and infestations	—

Other adverse events (4 terms — click to expand)

Reaction	System	Ultrasound Closure
Access Site Hematoma	Injury, poisoning and procedural complications	—
Vessel Dissection	Vascular disorders	—
Edema in left hand	Vascular disorders	—
Retroperitoneal Bleed	Gastrointestinal disorders	—

Most-reported serious reactions: Transient Ischemic Attack (TIA), Arrhythmia, Anemia, Systemic Infection.

Data from ClinicalTrials.gov NCT05142566 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.