Trial Outcomes & Findings for A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System (NCT NCT04144959)
NCT ID: NCT04144959
Last Updated: 2025-06-27
Results Overview
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
1-Month Post Procedure
Results posted on
2025-06-27
Participant Flow
Participant milestones
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System
Baseline characteristics by cohort
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=5 Participants
|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-Month Post ProcedurePopulation: The analysis population (ITT) contains 111 evaluable participants.
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=111 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Target Limb Salvage Rate
|
109 Participants
|
SECONDARY outcome
Timeframe: Immediate Post ProcedurePopulation: The analysis population (ITT) contains 109 evaluable participants.
Defined as TIMI 2/3 flow rate TIMI flow grade: Grade 0 No perfusion Grade 1 Perfusion past initial occlusion but no distal branch filling. Grade 2 Perfusion with incomplete or slow distal branch filling. Grade 3 Full perfusion with filling of all distal branches.
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=109 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Technical Success
|
105 Participants
|
SECONDARY outcome
Timeframe: Pre Procedure and immediately Post ProcedurePopulation: The analysis population (ITT) contains 106 evaluable participants.
Endpoint is change in modified SVS Runoff Score at post-procedure Modified SVS runoff score ranges from 1-19, with a higher score indicating more severe disease
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=106 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Modified Society for Vascular Surgery Runoff Score
|
6.3 Change in Modified SVS runoff score
Standard Deviation 5.49
|
SECONDARY outcome
Timeframe: Up to discharge or 7 days, whichever occurred firstPopulation: The analysis population (ITT) contains 96 evaluable participants.
Improvement of one or more as compared to pre-procedure Rutherford classification: I.Viable Not immediately threatened IIa.Threatened Marginally Salvageable if promptly treated IIb. Threatened Immediately Salvageable with immediate revascularization III. Irreversible
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=96 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Improvement of Rutherford Classification
|
83 Participants
|
SECONDARY outcome
Timeframe: 1-Month Post-ProcedurePopulation: The analysis population (ITT) contains 113 evaluable participants
Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (\>50 %, ) and without target lesion reintervention (TLR ).
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=113 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Vessel Patency
|
101 Participants
|
SECONDARY outcome
Timeframe: 12-Months Post ProcedurePopulation: The analysis population (ITT) contains 81 evaluable participants.
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=81 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Target Limb Salvage Rate
|
72 Participants
|
SECONDARY outcome
Timeframe: Up until study completion, at approximately 12-MonthsPopulation: The analysis population (ITT) contains 119 evaluable participants.
A SAE is an event that led to death, led to a serious deterioration in the health of the patient that resulted in life-threatening illness or injury, resulted in chronic disease, resulted in permanent impairment of a body structure or a body function, required in-patient hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function, led to fetal distress, fetal death or a congenital abnormality or birth defect
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Rates of Device Related Serious Adverse Events (SAEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: within 2 days of procedureFatal or leading to a drop in hemoglobin of ≥5 g /dl, or significant hypotension with the need for inotropes, or requiring surgery (other than vascular site repair ), or symptomatic intracranial hemorrhage (ICH ), or requiring transfusion of two or three units of red blood cells or equivalent whole blood
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Major Bleeding Peri-procedure
|
5 Participants
|
SECONDARY outcome
Timeframe: 12-MonthsPopulation: The analysis population contains all participants who were enrolled. All deaths within 365 days are included.
Death due to any cause
Outcome measures
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 Participants
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Mortality
|
12 Participants
|
Adverse Events
Patients With Lower Extremity Acute Limb Ischemia
Serious events: 90 serious events
Other events: 15 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 participants at risk
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
5/119 • Number of events 5 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Cardiac failure
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Cardiac failure acute
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Cardiogenic shock
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Gastrointestinal disorders
Colitis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Amputation stump pain
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Death
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Impaired healing
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Oedema peripheral
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Pain
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Vascular stent occlusion
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Vascular stent stenosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
General disorders
Vascular stent thrombosis
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
COVID-19
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Cellulitis
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Cystitis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Diabetic foot infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Endocarditis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Gangrene
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Localised infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Osteomyelitis
|
2.5%
3/119 • Number of events 4 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Postoperative wound infection
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
pyelonephritis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Sepsis
|
3.4%
4/119 • Number of events 4 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Septic shock
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Skin graft infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Staphylococcal infection
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
4/119 • Number of events 6 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Vascular access site infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Vascular graft infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Wound infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Arterial bypass stenosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Incision site impaired healing
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Postoperative wound infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.84%
1/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
3.4%
4/119 • Number of events 4 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Metabolism and nutrition disorders
Acute respiratory failure
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
3.4%
4/119 • Number of events 4 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.84%
1/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Plantar facial fibromatosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma recurrent
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Embolic stroke
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Generalised tonic clonic seizure
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Ischaemic stroke
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.84%
1/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Seizure
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Syncope
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Psychiatric disorders
Delirium
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Psychiatric disorders
Mental status change
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Renal and urinary disorders
Calculus bladder
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Renal and urinary disorders
Hydroponephrosis
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Surgical and medical procedures
Toe amputation
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Aortic dissection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Arterial bypass stenosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Haematoma
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Haemorrhage
|
13.4%
16/119 • Number of events 16 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Hypertensive urgency
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral artery occlusion
|
5.0%
6/119 • Number of events 8 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral artery stenosis
|
2.5%
3/119 • Number of events 3 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral artery thrombosis
|
5.0%
6/119 • Number of events 7 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral embolism
|
3.4%
4/119 • Number of events 5 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral ischaemia
|
13.4%
16/119 • Number of events 18 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Vascular dissection
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Vascular stent occlusion
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
Other adverse events
| Measure |
Patients With Lower Extremity Acute Limb Ischemia
n=119 participants at risk
Indigo Aspiration System: Indigo Aspiration System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Postoperative wound infection
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Arterial spasm
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Arterial thrombosis
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Haematoma
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Haemorrhage
|
1.7%
2/119 • Number of events 2 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Hypotension
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Peripheral ischaemia
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
|
Vascular disorders
Vasospasm
|
0.84%
1/119 • Number of events 1 • All adverse events are reported for the duration a participant is in the study. All deaths within 365 days are included.
|
Additional Information
Erin Archard, Senior Director of Clinical Research, Vascular
Penumbra, Inc.
Phone: +1 802 377 9715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60