MedTrace Logo

Trial Outcomes & Findings for Comparison of Two Pulmonary Embolism Treatments (NCT NCT05684796)

NCT ID: NCT05684796

Last Updated: 2026-08-18

Results Overview

Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

48 hours post-randomization

Results posted on

2026-08-18

Participant Flow

Participant milestones

Participant milestones
Measure
Anticoagulation (AC)
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Overall Study
STARTED
53
47
Overall Study
COMPLETED
47
43
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Pulmonary Embolism Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Anticoagulation (AC)
n=53 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Total
n=100 Participants
Total of all reporting groups
Age, Continuous
61.2 years
STANDARD_DEVIATION 14.19 • n=298 Participants
59.5 years
STANDARD_DEVIATION 13.22 • n=102 Participants
60.4 years
STANDARD_DEVIATION 13.70 • n=400 Participants
Sex: Female, Male
Female
28 Participants
n=298 Participants
18 Participants
n=102 Participants
46 Participants
n=400 Participants
Sex: Female, Male
Male
25 Participants
n=298 Participants
29 Participants
n=102 Participants
54 Participants
n=400 Participants
Race/Ethnicity, Customized
Hispanic or Latino
0 Participants
n=298 Participants
3 Participants
n=102 Participants
3 Participants
n=400 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
49 Participants
n=298 Participants
37 Participants
n=102 Participants
86 Participants
n=400 Participants
Race/Ethnicity, Customized
Unknown
1 Participants
n=298 Participants
1 Participants
n=102 Participants
2 Participants
n=400 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants
n=298 Participants
3 Participants
n=102 Participants
3 Participants
n=400 Participants
Race/Ethnicity, Customized
Not collected due to local privacy regulations
3 Participants
n=298 Participants
3 Participants
n=102 Participants
6 Participants
n=400 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race/Ethnicity, Customized
Black or African American
13 Participants
n=298 Participants
18 Participants
n=102 Participants
31 Participants
n=400 Participants
Race/Ethnicity, Customized
White
35 Participants
n=298 Participants
22 Participants
n=102 Participants
57 Participants
n=400 Participants
Race/Ethnicity, Customized
More than one race
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
1 Participants
n=298 Participants
4 Participants
n=102 Participants
5 Participants
n=400 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=298 Participants
0 Participants
n=102 Participants
1 Participants
n=400 Participants

PRIMARY outcome

Timeframe: 48 hours post-randomization

Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=52 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=46 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Change in RV/LV Ratio
-0.24 Change in RV/LV Ratio
Standard Deviation 0.40
-0.52 Change in RV/LV Ratio
Standard Deviation 0.37

SECONDARY outcome

Timeframe: within 7 days post-randomization

Major adverse events (MAEs) within 7 days: a composite of clinical deterioration requiring escalation of care, PE-related mortality, symptomatic recurrent PE, or major bleeding

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=53 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Major Adverse Events
4 Participants
2 Participants

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Functional outcome as assessed by the 6-minute walk test (6MWT) through 90 days. The 6-minute walk test measures distance walked in meters, with longer distances being better.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=34 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=31 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Functional Outcome Assessment With the 6-minute Walk Test
368.0 distance walked in meters
Standard Deviation 127.78
478.7 distance walked in meters
Standard Deviation 159.47

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Functional outcome as assessed by the New York Heart Association classification (NYHA) through 90 days. The New York Heart Association classification ranges from Class I (no limitations) -IV (severe limitation), with higher classifications being worse.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=45 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=38 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Functional Outcome Assessment With the New York Heart Association Classification
Class IV
1 Participants
0 Participants
Functional Outcome Assessment With the New York Heart Association Classification
Class III
2 Participants
1 Participants
Functional Outcome Assessment With the New York Heart Association Classification
Class II
8 Participants
0 Participants
Functional Outcome Assessment With the New York Heart Association Classification
Class I
34 Participants
37 Participants

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Functional outcome as assessed by the Post Venous Thromboembolism Functional Status (PVFS) scale through 90 days. The Post Venous Thromboembolism Functional Status scale ranges from 0-5, with higher scores being worse.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=44 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=39 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Severe functional limitations
3 Participants
1 Participants
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Moderate
3 Participants
2 Participants
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Slight
7 Participants
8 Participants
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Negligible
8 Participants
5 Participants
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
No functional limitations
23 Participants
23 Participants

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Functional outcome as assessed by the modified Medical Research Council Dyspnea Scale (mMRC) through 90 days. The modified Medical Research Council Dyspnea Scale ranges from 0-4, with higher scores being worse.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=44 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=39 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Functional Outcome Assessment With the Modified Medical Research Council Dyspnea Scale
0.6 score on a scale
Standard Deviation 0.95
0.4 score on a scale
Standard Deviation 0.94

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=44 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=37 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Functional Outcome Assessment With the Borg Scale
0 score on a scale
Interval 0.0 to 0.3
0 score on a scale
Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Quality of Life (QoL), as assessed by the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) through 90 days. The Pulmonary Embolism Quality of Life Questionnaire measures the percent of life affected by PE across 6 dimensions (including: Frequency of complaints, Limitations in activities of daily living (ADL), Work-related problems, Social limitations, Intensity of complaints, Emotional complaints), with higher scores being worse.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=45 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=39 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Quality of Life Assessment With the Pulmonary Embolism Quality of Life Questionnaire
21.7 percent of life affected by PE
Standard Deviation 22.0
15.8 percent of life affected by PE
Standard Deviation 20.0

SECONDARY outcome

Timeframe: Through 90 days post-randomization

Quality of Life (QoL), as assessed by the EQ-5D-5L Questionnaire through 90 days. The EQ-5D-5L index is a preference-weighted measure of health status derived from five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Index values represent overall health status, with higher scores indicating better health status. The Visual Analogue Scale (VAS) scale is part of the questionnaire and ranges from 0-100, with higher scores being better.

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=44 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=39 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Quality of Life Assessment With the EQ-5D-5L Questionnaire
Index
0.811 score on a scale
Standard Deviation 0.221
0.811 score on a scale
Standard Deviation 0.236
Quality of Life Assessment With the EQ-5D-5L Questionnaire
Visual Analog Scale
77.9 score on a scale
Standard Deviation 18.2
80.2 score on a scale
Standard Deviation 14.9

SECONDARY outcome

Timeframe: within 90 days post-randomization

All-cause mortality within 90 days

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=53 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
All-cause Mortality
1 Participants
4 Participants

SECONDARY outcome

Timeframe: within 90 days post-randomization

PE-related mortality within 90 days

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=53 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
PE-related Mortality
0 Participants
2 Participants

SECONDARY outcome

Timeframe: within 90 days post-randomization

Symptomatic PE recurrence within 90 days

Outcome measures

Outcome measures
Measure
Anticoagulation (AC)
n=53 Participants
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 Participants
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Symptomatic PE Recurrence
1 Participants
1 Participants

Adverse Events

Anticoagulation (AC)

Serious events: 14 serious events
Other events: 5 other events
Deaths: 1 deaths

Indigo

Serious events: 11 serious events
Other events: 8 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Anticoagulation (AC)
n=53 participants at risk
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 participants at risk
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the gastroesophageal junction
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Persistent Shortness of Breath
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Residual Pulmonary Embolism
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Vascular disorders
Hemorrhagic shock secondary to gross hematuria
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Severe shortness of breath
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Cardiac disorders
Cardiac arrest
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Injury, poisoning and procedural complications
Left radial artery bleed
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Vascular disorders
New acute bilateral LE DVT and edema
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Worsening hemothorax
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Cardiac disorders
Thrombus traversing from Right Atrium to Left Atrium through Patent Foramen Ovale (PFO)
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Hemoptysis
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Persistent Hypoxia
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Infections and infestations
Urinary Tract Infection
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Cardiac disorders
SVT event
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Immune system disorders
Anaphylactic Shock
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Injury, poisoning and procedural complications
Trauma (due to multiple gunshot wounds head, face, groin, R hip, L buttock)
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Cardiac disorders
Severe Tachycardia
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Recurrent Pulmonary Embolism
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Vascular disorders
Hypertensive Emergency
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
General disorders
Death
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Re-Demonstration of Saddle Pulmonary Embolism
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Subglottic Stenosis
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Infections and infestations
Influenza
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Infections and infestations
Left upper lobe pneumonia
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization

Other adverse events

Other adverse events
Measure
Anticoagulation (AC)
n=53 participants at risk
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Anticoagulation: Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Indigo
n=47 participants at risk
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. mechanical aspiration thrombectomy: Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Infections and infestations
Pneumonia
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Gastrointestinal disorders
Duodenal Ulcers
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Vascular disorders
Deep Vein Thrombosis
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Respiratory, thoracic and mediastinal disorders
Hemoptysis
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Renal and urinary disorders
AKI
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Infections and infestations
Worsening Urinary Tract Infection
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Immune system disorders
Severe Allergic Reaction
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
Cardiac disorders
New Onset Atrial Fibrillation with RVR
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Cardiac disorders
Worsening of Atrial fibrillation
1.9%
1/53 • 90 days post-randomization
0.00%
0/47 • 90 days post-randomization
Skin and subcutaneous tissue disorders
Perivascular Lymphocytic
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
General disorders
Chest pain and SOB
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization
General disorders
Chest Pain
0.00%
0/53 • 90 days post-randomization
2.1%
1/47 • 90 days post-randomization

Additional Information

Meghan Beatty

Penumbra, Inc.

Phone: 757.759.2898

Results disclosure agreements

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

Restriction type: LTE60