Peripheral Arterial Occlusion or Emboli
Conditions
Keywords
peripheral arterial occlusion, visceral emboli, limb ischemia, adverse events, Indigo System, aspiration, mechanical thrombectomy
Brief summary
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.
Interventions
DEVICEMechanical Thrombectomy by the Indigo System
Sponsors
Penumbra Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment. * Treatment with components of the Penumbra and/or Indigo System.
Exclusion criteria
* Participation in another clinical investigation that may confound the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores | Immediate post-procedure | Proportion of patients with a post-procedure TIMI score of 2 to 3. |
| Procedural Serious Adverse Events | During the procedure | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mechanical Thrombectomy by the Indigo System Mechanical Thrombectomy by the Indigo System | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Mechanical Thrombectomy by the Indigo System |
|---|---|
| Age, Continuous | 68.5 Years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 85 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 85 |
| other Total, other adverse events | 27 / 85 |
| serious Total, serious adverse events | 15 / 85 |
Outcome results
Primary
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores
Proportion of patients with a post-procedure TIMI score of 2 to 3.
Time frame: Immediate post-procedure
Population: TIMI score at immediate post-procedure was unavailable for one patient.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy by the Indigo System | Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores | 74 Participants |
Primary
Procedural Serious Adverse Events
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy by the Indigo System | Procedural Serious Adverse Events | 5 Participants |