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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical thrombectomy by the Indigo System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy by the Indigo System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate post-procedure |
| Procedural Serious Adverse Events | During the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Saxon, MD | Tri-City Medical Center, San Diego, CA | Principal Investigator |
| Corey Teigen, MD | Sanford Medical Center Fargo, ND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-City Medical Center | San Diego | California | 92123 | United States | ||
| Baptist Health South Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mechanical Thrombectomy by the Indigo System | Mechanical Thrombectomy by the Indigo System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mechanical Thrombectomy by the Indigo System | Mechanical Thrombectomy by the Indigo System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | TIMI score at immediate post-procedure was unavailable for one patient. | Posted | Count of Participants | Participants | Immediate post-procedure |
|
|
up to 24 hours after procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mechanical Thrombectomy by the Indigo System | Mechanical Thrombectomy by the Indigo System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaella Corso | Penumbra, Inc. | +1 510-995-2079 | mcorso@penumbrainc.com |
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| ID | Term |
|---|---|
| D004617 | Embolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Miami |
| Florida |
| 33176 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58122 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Procedural Serious Adverse Events | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| 0 |
| 85 |
| 15 |
| 85 |
| 27 |
| 85 |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal Ischaemia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Leg Amputation | Surgical and medical procedures | Non-systematic Assessment |
|
| Myocardial Infarction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pulseless Electrical Activity | Cardiac disorders | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Shock | Vascular disorders | Non-systematic Assessment |
|
| Systemic Inflammatory Response Syndrome | Immune system disorders | Non-systematic Assessment |
|
| Vascular Pseudoaneurysm Ruptured | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vessel Puncture Site Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Clostridium Difficule Colitis | Infections and infestations | Non-systematic Assessment |
|
| Embolism | Vascular disorders | Non-systematic Assessment |
|
| Epistaxis | Vascular disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haematuria | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Heparin-Induced Thrombocytopenia | General disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Intestinal Ischaemia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Leg Amputation | Surgical and medical procedures | Non-systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Pulseless Electrical Activity | Cardiac disorders | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | Non-systematic Assessment |
|
| Shock | Cardiac disorders | Non-systematic Assessment |
|
| Systemic Inflammatory Response Syndrome | Immune system disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Vascular Pseudoaneurysm Ruptured | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vasospasm | Vascular disorders | Non-systematic Assessment |
|
| Vessel Puncture Site Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Visual Impairment | Eye disorders | Non-systematic Assessment |
|
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