Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
Study Overview
Status
Status
Conditions
Conditions
- Peripheral Arterial Disease
- Acute Limb Ischemia
- DVT
- Deep Vein Thrombosis Leg
- Lower Extremity Acute Limb Ischemia
- LE ALI
- Chronic DVT of Lower Extremity
- Acute DVT of Lower Extremity
- Thrombus in the Peripheral Venous Vasculature
- Venous Embolism of Lower Extremities (Diagnosis)
- Arterial Embolism and Thrombosis
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Manasa Gudipally
- Phone Number: 763-514-4000
- Email: manasa.gudipally@medtronic.com
Study Contact Backup
- Name: Elizabeth Hunt
- Email: elizabeth.m.hunt@medtronic.com
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 003329
- Recruiting
- Medstar Health
-
Contact:
- Manasa Gudipally
-
-
Florida
-
Naples, Florida, United States, 34108
- Recruiting
- Naples Comprehensive Health
-
Contact:
- Manasa Gudipally
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Mount Sinai
-
Contact:
- Manasa Gudipally
- Email: manasa.gudipally@medtronic.com
-
-
Texas
-
Plano, Texas, United States, 75093
- Recruiting
- Baylor Heart Hospital Of Plano
-
Contact:
- Manasa Gudipally
- Email: manasa.gudipally@medtronic.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria:
- Patient treated is age ≥ 22 years at the time of procedure
- Use of Liberant in accordance with the device labeling within 72 hours of index procedure
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Device related Serious Adverse Event at Index procedure
Time Frame: Index Procedure
|
An Adverse Event that converted to Serious Adverse Event, involving the function of the subject device, or the presence of the device in the body, including events that are directly attributable to the Liberant Thrombectomy System
|
Index Procedure
|
|
Rate of technical success at Index procedure
Time Frame: Index procedure
|
Technical success: Successful introduction, delivery, aspiration of fresh, soft emboli or thrombi, and retrieval of the Liberant per the Instructions for Use (IFU) during the index procedure
|
Index procedure
|
|
Rate of Procedural Success at Index procedure
Time Frame: Index procedure
|
Procedure success: Successful removal of fresh, soft emboli or thrombi and restoration of adequate blood flow, inclusive of all endovascular therapies during the index procedure
|
Index procedure
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: John R Laird Jr, MD, Medtronic Endovascular
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
- Vascular Diseases
- Thrombectomy
- Aspiration
- Thrombosis
- adverse events
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Venous Thrombosis
- Mechanical Thrombectomy
- Aspiration Thrombectomy
- Arterial Occlusive Diseases
- Percutaneous Mechanical Thrombectomy
- Thrombus in Peripheral Arterial Systems
- Excipio
- Liberant Thrombectomy System
- Thrombus in Peripheral Venous Systems
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MDT25034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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