Trial Outcomes & Findings for Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism (NCT NCT03218566)
NCT ID: NCT03218566
Last Updated: 2020-08-03
Results Overview
Change in RV/LV ratio per CTA
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
from baseline to 48 hours
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
Indigo Aspiration System
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI specific to female population.
Baseline characteristics by cohort
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=119 Participants
|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 14.98 • n=119 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=119 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=119 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=119 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=119 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=119 Participants
|
|
BMI-Females
|
36.7 kg/m^2
STANDARD_DEVIATION 10.39 • n=53 Participants • BMI specific to female population.
|
|
BMI-Males
|
31.7 kg/m^2
STANDARD_DEVIATION 6.60 • n=66 Participants • BMI specific to male population.
|
PRIMARY outcome
Timeframe: from baseline to 48 hoursPopulation: The intent-to-treat population calculating the change between the baseline and the 48 hours RV/LV diameter ratio
Change in RV/LV ratio per CTA
Outcome measures
| Measure |
Single Arm
n=113 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Right Ventricle/Left Ventricle (RV:LV) Ratio
|
0.43 Change in RV/LV Diameter Ratio
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: within 48 hoursA composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Outcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Major Adverse Event Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: within 48 hoursOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Device-related Death Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: within 48 hoursOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Major Bleeding Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: within 48 hoursOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Clinical Deterioration Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: within 48 hoursOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Pulmonary Vascular Injury Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: within 48 hoursOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Cardiac Injury Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: within 30 daysOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Any-cause Mortality
|
3 Participants
|
SECONDARY outcome
Timeframe: within 30 daysOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Device-related SAE Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: within 30 daysOutcome measures
| Measure |
Single Arm
n=119 Participants
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Symptomatic PE Recurrence Rate
|
0 Participants
|
Adverse Events
Single Arm
Serious events: 13 serious events
Other events: 56 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Single Arm
n=119 participants at risk
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Cardiac disorders
Cardio-respiratory Arrest
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Cardiomyopathy
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Cellulitis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Sepsis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Metastatic
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Cerebral infarction
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Stroke in Evolution
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.84%
1/119 • Within 30 days post-procedure
|
Other adverse events
| Measure |
Single Arm
n=119 participants at risk
Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
5/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Arrhythmia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
2/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Atrial Flutter
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Extrasystoles
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Cardiac disorders
Tachyarrhythmia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Abnormal Faeces
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Constipation
|
2.5%
3/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Gastrointestinal disorders
Oesophagitis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
General disorders
Asthenia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
General disorders
Chest Pain
|
3.4%
4/119 • Within 30 days post-procedure
|
|
General disorders
Fatigue
|
1.7%
2/119 • Within 30 days post-procedure
|
|
General disorders
Hernia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
General disorders
Oedema Peripheral
|
0.84%
1/119 • Within 30 days post-procedure
|
|
General disorders
Vessel Puncture Site Pain
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Bronchitis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Fungal Infection
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Pneumonia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Infections and infestations
Urinary Tract Infection
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
2.5%
3/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Contusion
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular Access Site Hemorrhage
|
1.7%
2/119 • Within 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Gout
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.4%
4/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Dizziness
|
1.7%
2/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Headache
|
2.5%
3/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Presyncope
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Syncope
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Nervous system disorders
Unresponsive To Stimuli
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.5%
3/119 • Within 30 days post-procedure
|
|
Renal and urinary disorders
Haematuria
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Renal and urinary disorders
Urinary Retention
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
2/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.2%
5/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
2/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.4%
4/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.84%
1/119 • Within 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discoloured
|
0.84%
1/119 • Within 30 days post-procedure
|
Additional Information
Erin Archard, Sr. Clinical Study Manager
Penumbra, Inc.
Phone: +1 510 995 9801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60