Pulmonary Embolism
Conditions
Keywords
pulmonary embolism, clot
Brief summary
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Interventions
DEVICEIndigo Aspiration System
use of mechanical thrombectomy to treat pulmonary embolism
Sponsors
Penumbra Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA. * Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio \> 0.9 * Patient is 18 years of age or older
Exclusion criteria
* tPA use within 14 days prior to baseline CTA * Systolic BP \< 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg * Pulmonary hypertension with peak PA \> 70 mmHg by right heart catheterization * History of severe or chronic pulmonary hypertension * Fi02 requirement \> 40% or \>6 LPM to keep oxygen saturations \>90% * Hematocrit \< 28% * Platelets \< 100,000µL * Serum creatinine \> 1.8 mg/dL * INR \> 3 * aPTT (or PTT) \> 50 seconds on no anticoagulation * History of heparin-induced thrombocytopenia (HIT) * Contraindication to systemic or therapeutic doses of anticoagulants * Major trauma \< 14 days * Presence of intracardiac lead * Cardiovascular or pulmonary surgery within last 7 days * Cancer requiring active chemotherapy * Known serious, uncontrolled sensitivity to radiographic agents * Life expectancy \< 90 days * Female who is pregnant * Intracardiac Thrombus * Patients on ECMO * Current participation in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Right Ventricle/Left Ventricle (RV:LV) Ratio | from baseline to 48 hours | Change in RV/LV ratio per CTA |
| Major Adverse Event Rate | within 48 hours | A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury) |
Secondary
| Measure | Time frame |
|---|---|
| Device-related Death Rate | within 48 hours |
| Major Bleeding Rate | within 48 hours |
| Clinical Deterioration Rate | within 48 hours |
| Pulmonary Vascular Injury Rate | within 48 hours |
| Cardiac Injury Rate | within 48 hours |
| Any-cause Mortality | within 30 days |
| Device-related SAE Rate | within 30 days |
| Symptomatic PE Recurrence Rate | within 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism
Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants |
| Age, Continuous | 59.8 Years STANDARD_DEVIATION 14.98 |
| BMI-Females | 36.7 kg/m^2 STANDARD_DEVIATION 10.39 |
| BMI-Males | 31.7 kg/m^2 STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Region of Enrollment United States | 119 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 119 |
| other Total, other adverse events | 56 / 119 |
| serious Total, serious adverse events | 13 / 119 |
Outcome results
Primary
Major Adverse Event Rate
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Major Adverse Event Rate | 2 Participants |
Primary
Right Ventricle/Left Ventricle (RV:LV) Ratio
Change in RV/LV ratio per CTA
Time frame: from baseline to 48 hours
Population: The intent-to-treat population calculating the change between the baseline and the 48 hours RV/LV diameter ratio
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Right Ventricle/Left Ventricle (RV:LV) Ratio | 0.43 Change in RV/LV Diameter Ratio | Standard Deviation 0.26 |
Secondary
Any-cause Mortality
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Any-cause Mortality | 3 Participants |
Secondary
Cardiac Injury Rate
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Cardiac Injury Rate | 0 Participants |
Secondary
Clinical Deterioration Rate
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Clinical Deterioration Rate | 2 Participants |
Secondary
Device-related Death Rate
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Device-related Death Rate | 1 Participants |
Secondary
Device-related SAE Rate
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Device-related SAE Rate | 2 Participants |
Secondary
Major Bleeding Rate
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Major Bleeding Rate | 2 Participants |
Secondary
Pulmonary Vascular Injury Rate
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Pulmonary Vascular Injury Rate | 2 Participants |
Secondary
Symptomatic PE Recurrence Rate
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Symptomatic PE Recurrence Rate | 0 Participants |