Trial Outcomes & Findings for The PROTEMBO C Trial (NCT NCT04618718)
NCT ID: NCT04618718
Last Updated: 2025-05-08
Results Overview
Number of participants experiencing a Major Adverse Cardiac and Cerebrovascular Event (MACCE) defined by VARC-2 including all-cause mortality, all stroke, life-threatening or disabling bleeding, vascular injury and acute kidney injury (stage 2 or 3) within 30 days of the procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
30 days post-procedure
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Intervention
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Overall Study
STARTED
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64
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Overall Study
COMPLETED
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64
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PROTEMBO C Trial
Baseline characteristics by cohort
| Measure |
Intervention
n=64 Participants
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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63 Participants
n=5 Participants
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Age, Continuous
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79 years
STANDARD_DEVIATION 5.1 • n=5 Participants
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Sex: Female, Male
Female
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35 Participants
n=5 Participants
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Sex: Female, Male
Male
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29 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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64 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Latvia
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5 participants
n=5 Participants
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Region of Enrollment
Poland
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39 participants
n=5 Participants
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Region of Enrollment
Germany
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20 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30 days post-procedureNumber of participants experiencing a Major Adverse Cardiac and Cerebrovascular Event (MACCE) defined by VARC-2 including all-cause mortality, all stroke, life-threatening or disabling bleeding, vascular injury and acute kidney injury (stage 2 or 3) within 30 days of the procedure
Outcome measures
| Measure |
Intervention
n=64 Participants
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Rate of Participants With MACCE Events
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3 Participants
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PRIMARY outcome
Timeframe: During the procedureNumber of participants in whom technical success was achieved during the procedure. Technical success is defined as the ability to safely deliver, deploy, and remove the device, ability to secure positioning and stability of the position throughout the transcatheter intracardiac procedure and ability to deflect embolic material as assessed by adequate coverage while not impeding blood flow, deployed and removed and positioning and stability of the device
Outcome measures
| Measure |
Intervention
n=60 Participants
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Rate of Participants in Whom Technical Success Was Achieved
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57 Participants
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SECONDARY outcome
Timeframe: 2-7 days post-procedureComparison between the median new lesion volume in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI) at 2-7 days and historical data; the total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-procedural DW-MRI relative to the pre-TAVR DW-MRI
Outcome measures
| Measure |
Intervention
n=51 Participants
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Efficacy-MR Imaging: Comparison Between the Median New Lesion Volume in the Brain
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210 mm3
Interval 108.0 to 566.0
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SECONDARY outcome
Timeframe: 3 days post-procedureDeath or all stroke according to VARC-2 criteria (to define occurrence and type stroke) within 3 days (72 hours) of the TAVR procedure compared to historical data
Outcome measures
| Measure |
Intervention
n=64 Participants
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Composite Rate of Death or All Strokes
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1 Participants
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Adverse Events
Intervention
Serious events: 20 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=64 participants at risk
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Blood and lymphatic system disorders
Drop in Hemoglobin
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
1st degree AV Block
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
3rd degree AV block
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6.2%
4/64 • Number of events 4 • 30 days (+/- 7 days)
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Cardiac disorders
Bradycardia
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
Left Bundle Branch Block
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4.7%
3/64 • Number of events 3 • 30 days (+/- 7 days)
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Infections and infestations
Urinary Tract Infection
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Nervous system disorders
Cerebral Infarction
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Renal and urinary disorders
Acute Kidney Injury
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3.1%
2/64 • Number of events 2 • 30 days (+/- 7 days)
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Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Surgical and medical procedures
Cardiac Tamponade/Sternotomy
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Surgical and medical procedures
Radial artery dissection
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Surgical and medical procedures
Sedative Circulatory Complication
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Surgical and medical procedures
TAVR access site complication
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4.7%
3/64 • Number of events 3 • 30 days (+/- 7 days)
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Other adverse events
| Measure |
Intervention
n=64 participants at risk
ProtEmbo device will be used as distal protection device in subjects undergoing TAVR cerebral embolic protection during TAVR: The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
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|---|---|
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Blood and lymphatic system disorders
Abnormal Alkaline Phosphatase and Gamma GT
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Blood and lymphatic system disorders
Anemia
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
Atrial Fibrillation
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4.7%
3/64 • Number of events 3 • 30 days (+/- 7 days)
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Cardiac disorders
Cardiac Arrhythmia
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
Hypertension
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
|
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Cardiac disorders
Left Anterior Fascicular Block
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Cardiac disorders
Left Bundle Branch Block
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3.1%
2/64 • Number of events 2 • 30 days (+/- 7 days)
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Infections and infestations
Diarrhea
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Musculoskeletal and connective tissue disorders
Loss of Sphincter Tone
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Renal and urinary disorders
Hematuria
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Surgical and medical procedures
Radial Artery Occlusion
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3.1%
2/64 • Number of events 2 • 30 days (+/- 7 days)
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Surgical and medical procedures
Postoperative nausea and vomitting/ vertigo
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Nervous system disorders
Short period of delirium post TAVR
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1.6%
1/64 • Number of events 1 • 30 days (+/- 7 days)
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Vascular disorders
TAVR access site hematoma
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3.1%
2/64 • Number of events 2 • 30 days (+/- 7 days)
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Vascular disorders
Vascular access site hematoma
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3.1%
2/64 • Number of events 2 • 30 days (+/- 7 days)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place