LE ALI, Lower Extremity Acute Limb Ischemia
Conditions
Brief summary
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
Interventions
DEVICEIndigo Aspiration System
Indigo Aspiration System
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age ≥ 18 * Patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament) * Patient with a Rutherford Category I, IIa or IIb score * Frontline treatment with Indigo Aspiration System * Informed consent is obtained from either patient or legally authorized representative (LAR)
Exclusion criteria
* Life expectancy \<1 year * Vessel size \<2 mm * LE ALI secondary to dissections, vasculitis, and/or target vessel trauma * Amputation in the ipsilateral limb * Pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable) * Absolute contraindication to contrast administration * Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate * Currently participating in an investigational drug or device clinical trial that may confound the study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Limb Salvage Rate | 1-Month Post Procedure | Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Society for Vascular Surgery Runoff Score | Pre Procedure and immediately Post Procedure | 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 |
| Improvement of Rutherford Classification | Up to discharge or 7 days, whichever occurred first | 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 |
| Vessel Patency | 1-Month Post-Procedure | Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (\>50 %, ) and without target lesion reintervention (TLR ). |
| Technical Success | Immediate Post Procedure | 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. |
| Rates of Device Related Serious Adverse Events (SAEs) | Up until study completion, at approximately 12-Months | 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 |
| Major Bleeding Peri-procedure | within 2 days of procedure | Fatal 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 |
| Mortality | 12-Months | Death due to any cause |
| Target Limb Salvage Rate | 12-Months Post Procedure | Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint) |
Countries
Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Lower Extremity Acute Limb Ischemia Indigo Aspiration System: Indigo Aspiration System | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | Patients With Lower Extremity Acute Limb Ischemia |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 65 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 66.3 Years STANDARD_DEVIATION 13.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 119 |
| other Total, other adverse events | 15 / 119 |
| serious Total, serious adverse events | 90 / 119 |
Outcome results
Primary
Target Limb Salvage Rate
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Time frame: 1-Month Post Procedure
Population: The analysis population (ITT) contains 111 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Target Limb Salvage Rate | 109 Participants |
Secondary
Improvement of Rutherford Classification
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
Time frame: Up to discharge or 7 days, whichever occurred first
Population: The analysis population (ITT) contains 96 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Improvement of Rutherford Classification | 83 Participants |
Secondary
Major Bleeding Peri-procedure
Fatal 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
Time frame: within 2 days of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Major Bleeding Peri-procedure | 5 Participants |
Secondary
Modified Society for Vascular Surgery Runoff Score
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
Time frame: Pre Procedure and immediately Post Procedure
Population: The analysis population (ITT) contains 106 evaluable participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Modified Society for Vascular Surgery Runoff Score | 6.3 Change in Modified SVS runoff score | Standard Deviation 5.49 |
Secondary
Mortality
Death due to any cause
Time frame: 12-Months
Population: The analysis population contains all participants who were enrolled. All deaths within 365 days are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Mortality | 12 Participants |
Secondary
Rates of Device Related Serious Adverse Events (SAEs)
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
Time frame: Up until study completion, at approximately 12-Months
Population: The analysis population (ITT) contains 119 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Rates of Device Related Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Target Limb Salvage Rate
Proportion of participants who did not have a major amputation (above the level of the tarsometatarsal joint)
Time frame: 12-Months Post Procedure
Population: The analysis population (ITT) contains 81 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Target Limb Salvage Rate | 72 Participants |
Secondary
Technical Success
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.
Time frame: Immediate Post Procedure
Population: The analysis population (ITT) contains 109 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Technical Success | 105 Participants |
Secondary
Vessel Patency
Patency is defined as a target lesion without a hemodynamically significant stenosis /reocclusion on duplex ultrasound (\>50 %, ) and without target lesion reintervention (TLR ).
Time frame: 1-Month Post-Procedure
Population: The analysis population (ITT) contains 113 evaluable participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Lower Extremity Acute Limb Ischemia | Vessel Patency | 101 Participants |