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The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sundt Carotid Shunt | Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sundt carotid shunt | Device | The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal | Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal | up to 60 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects participating in the study have undergone a carotid endarterectomy procedure with the use of the Sundt™ carotid shunt prior to study initiation.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tummon | Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Deaconess Clinic | Newburgh | Indiana | 47630 | United States | ||
| Hackensack Meridian Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sundt Carotid Shunt | Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sundt Carotid Shunt | Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt. |
| 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 | Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal | Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal | number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal | Posted | Count of Participants | Participants | up to 60 days post-procedure |
|
|
Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.
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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 | Sundt Carotid Shunt | number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Ischemia Injury | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Tummon, Director, Global Clinical Trials | Integra LifeSciences | 609-936-5490 | andrew.tummon@integralife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2018 | Dec 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2019 | Sep 20, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Hackensack |
| New Jersey |
| 07601 |
| United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Participants |
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 3 |
| 100 |
| Artery injury | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |