Trial Outcomes & Findings for Controlled Arterial Protection to Ultimately Remove Embolic Material (NCT NCT06103591)

NCT ID: NCT06103591

Last Updated: 2025-04-29

Results Overview

Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: During the procedure
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	EmStop Embolic Protection System Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Arterial Protection to Ultimately Remove Embolic Material

Baseline characteristics by cohort

Measure	EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Age, Continuous	79.07 years STANDARD_DEVIATION 5.54 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	15 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 United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: During the procedure

Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference

Outcome measures

Measure

EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Number of Participants With Procedural Success

14 Participants

PRIMARY outcome

Timeframe: 30 days follow-up

Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)

Outcome measures

Measure	EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days All-cause mortality	1 Participants
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days All stroke (disabling and non-disabling)	1 Participants
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days Acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours	0 Participants

SECONDARY outcome

Timeframe: During the procedure

Device filters were shipped to an independent pathology core laboratory where debris were counted and assessed

Outcome measures

Measure

EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Average Number of Captured Embolic Debris

3169.00 total number of captured particles Standard Deviation 2059.30

SECONDARY outcome

Timeframe: Procedural

Assessed by an independent pathology core laboratory

Outcome measures

Measure

EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Average Number of Captured Particles ≥140 μm in Diameter

3169.00 total number of captured particles Standard Deviation 2059.30

SECONDARY outcome

Timeframe: 14 days pre-procedure to 18-36 hours post-procedure

As measured by diffusion-weighted imaging (DWI), also referred to as DW-MRI. A baseline DW-MRI was collected and evaluated in comparison to the post-procedure DW-MRI.

Outcome measures

Measure

EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Total Acute Infarct Burden

14.93 lesions Standard Deviation 12.62

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure

EmStop Embolic Protection System n=15 Participants Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Occurrence of Transient Ischemic Attack (TIA)

0 Participants

Adverse Events

EmStop Embolic Protection System

Serious events: 6 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	EmStop Embolic Protection System n=15 participants at risk Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Cardiac disorders 1st Hb with Intermittent Complete Heart Block	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Stroke with metabolic encephalopathy and cardiac arrest	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Nervous system disorders Silent brain infarction	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Complete Heart Block	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Atrioventricular Block	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Symptomatic Bradycardia	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Decompensated Heart Failure	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Vascular disorders SVT Involving the Cephalic Vein	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).

Other adverse events

Measure	EmStop Embolic Protection System n=15 participants at risk Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System). The EmStop Embolic Protection System (EmStop System): The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.
Investigations New Onset Left Bundle Branch Block; Nonspecific St Abnormality; Nonspecific Intraventricular Block	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Cardiac disorders Conduction System Injury	6.7% 1/15 • Number of events 2 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).
Infections and infestations Virus	6.7% 1/15 • Number of events 1 • Adverse events (AEs) were collected from the time of subject enrollment through final 30 day follow-up and were adjudicated by an independent medical monitor. Adverse events were assessed at all visit timepoints (pre-discharge and 30-day follow up).

Additional Information

Phil Ebeling, CEO

EmStop, Inc.

Phone: 763-227-9954

Email: phil.ebeling@emstopeps.com

Results disclosure agreements

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