Trial Outcomes & Findings for MANTA Ultrasound Closure Study (NCT NCT05142566)

NCT ID: NCT05142566

Last Updated: 2023-07-27

Results Overview

adapted from VARC-2 Criteria

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: within 30 days
• Results posted on: 2023-07-27

Participant Flow

one subject was treated by a physician who was not officially trained and signed off on the protocol or device.

Participant milestones

Measure	Ultrasound Closure Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ultrasound Closure Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Overall Study Protocol Violation	1

Baseline Characteristics

MANTA Ultrasound Closure Study

Baseline characteristics by cohort

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Age, Continuous	80.06 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days

adapted from VARC-2 Criteria

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication	0 Participants

SECONDARY outcome

Timeframe: During the procedure

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

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Time to Hemostasis	.42 Minutes Interval 0.0 to 9.87

SECONDARY outcome

Timeframe: within 30 days

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

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Number of Patients With Technical Success	17 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Number of Subjects With Ambulation Success	17 Participants

SECONDARY outcome

Timeframe: During procedure admission

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

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Time to Ambulation	8.93 hours Interval 4.21 to 119.05

SECONDARY outcome

Timeframe: within 30 days

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

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Treatment Success	17 Participants

SECONDARY outcome

Timeframe: During the procedure

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

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Procedure Time	0.75 Hours Interval 0.61 to 1.62

SECONDARY outcome

Timeframe: within 30 days

adapted from VARC-2 Criteria

Outcome measures

Measure	Ultrasound Closure n=17 Participants Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication	1 Participants

Adverse Events

Ultrasound Closure

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ultrasound Closure n=17 participants at risk Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Nervous system disorders Transient Ischemic Attack (TIA)	11.8% 2/17 • Number of events 2 • Index procedure up to 30 days
Cardiac disorders Arrhythmia	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days
Infections and infestations Systemic Infection	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days

Other adverse events

Measure	Ultrasound Closure n=17 participants at risk Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Injury, poisoning and procedural complications Access Site Hematoma	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days
Vascular disorders Vessel Dissection	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days
Vascular disorders Edema in left hand	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days
Gastrointestinal disorders Retroperitoneal Bleed	5.9% 1/17 • Number of events 1 • Index procedure up to 30 days

Additional Information

Darra Bigelow, Sr. Manager, Clinical Operations

Essential Medical LLC (a subsidary of Teleflex, Inc.)

Phone: 610-331-7299

Email: darra.bigelow@teleflex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place