Trial Outcomes & Findings for Aventus Thrombectomy System Pulmonary Embolism Clinical Study (NCT NCT05907564)
NCT ID: NCT05907564
Last Updated: 2026-09-04
Results Overview
Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
at 48hrs compared to baseline
Results posted on
2026-09-04
Participant Flow
Participant milestones
| Measure |
Single Arm
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aventus Thrombectomy System Pulmonary Embolism Clinical Study
Baseline characteristics by cohort
| Measure |
Single Arm
n=120 Participants
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: at 48hrs compared to baselinePopulation: 48-hour CTA not completed in 3 patients. In addition one other patient refused the 48-hour CTA.
Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
Outcome measures
| Measure |
Single Arm
n=116 Participants
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
Change in RV/LV Ratio
|
.47 ratio
Standard Deviation .36
|
PRIMARY outcome
Timeframe: From Index Procedure to 48 hoursComposite of device related MAEs (major adverse events) including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
Outcome measures
| Measure |
Single Arm
n=120 Participants
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
Device Related Major Adverse Event Rate
|
0 Participants
|
Adverse Events
Single Arm
Serious events: 10 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=120 participants at risk
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
General disorders
Fall
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
Hematoma
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.7%
2/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Gastrointestinal disorders
Metastases to peritoneum
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Cardiac disorders
Pulmonary embolism
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
General disorders
SARS-CoV-2 test positive
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Gastrointestinal disorders
Adenocarcinoma gastric
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Cardiac disorders
Cardiac arrest
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Blood and lymphatic system disorders
Exsanguination
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
Other adverse events
| Measure |
Single Arm
n=120 participants at risk
Device: Aventus Thrombectomy System
Thrombectomy: Use of Aventus Thrombectomy System to treat pulmonary embolism
|
|---|---|
|
Vascular disorders
Oozing at access site
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
oral thrush
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Nervous system disorders
Orthostatic Hypotension
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
General disorders
Other-bilateral groi fungal infection.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Surgical and medical procedures
Other-occasional oozing with mild drainage from procedure site.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
General disorders
Pain
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Surgical and medical procedures
Post procedure access site oozing
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Infections and infestations
Rash
|
1.7%
2/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Surgical and medical procedures
right groin oozing
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
RSV
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Renal and urinary disorders
Urinary Retention
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Renal and urinary disorders
UTI
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
General disorders
Vertigo
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Reproductive system and breast disorders
yeast infection
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Reproductive system and breast disorders
Abnormal Vaginal Bleeding
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
access site bleed
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Nervous system disorders
Access site pain-right groin
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Renal and urinary disorders
Acute cystitis
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Renal and urinary disorders
Acute cystitis without hematuria
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Gastrointestinal disorders
anal fissure
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
Bilateral Lower Extremity Edema
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
Bleeding (Primarily documented as oozing) from the right groin access site.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
Bleeding from procedure site.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Cardiac disorders
chest pain
|
2.5%
3/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
DVT
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Hepatobiliary disorders
Elevated Liver Function Test (LFT), specifically elevated AST and ALT.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
General disorders
head cold
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Cardiac disorders
hematoma
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.7%
2/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Increase in cough.
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Vascular disorders
New R thigh swelling/bruising
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
nose bleed
|
0.83%
1/120 • From enrollment until the end of follow-up, up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place