PROWL: Pounce™ Thrombectomy System Retrospective Registry
Study Details
Study Description
Brief Summary
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Retrospective All subjects in whom the Pounce Thrombectomy System was attempted will be included. |
Device: Pounce Thrombectomy System
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Procedural Success [Peri-procedural (by the end of the index procedure)]
Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician
- Incidence of device related Major Adverse Events (MAEs) [Procedure to 30 days]
Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)
Secondary Outcome Measures
- Technical success [Peri-procedural (by the end of the index procedure)]
Restoration of blood flow to the target lesion(s) with <50% residual thrombus without the need to initiate CDT or to proceed to open surgery or other endovascular thrombectomy device as determined by the core lab
- Completeness of thromboemboli removal (by angiography) [Peri-procedural (by the end of the index procedure)]
Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician
- Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate [Peri-procedural (by the end of the index procedure)]
TIPI flow rate at the end of thrombectomy procedure and after any adjunctive procedures as determined by the core lab and physician.
- Modified Society for Vascular Surgery (SVS) runoff [Pre-procedure, Peri-procedural (by the end of the index procedure)]
Pre-procedure vs. post-procedure runoff using a modified SVS runoff score as determined by the core lab and physician (if applicable).
- Underlying atheroma stenosis [Peri-procedural (by the end of the index procedure)]
Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician
- Describe index procedural characteristics [Peri-procedural (by the end of the index procedure)]
Number of passes of Pounce Thrombectomy System Total number of passes Number of passes in each vessel
- Adjunctive procedures [Peri-procedural (by the end of the index procedure)]
Percentage of subjects in whom adjunctive procedures were performed ▪ Treatment for: underlying atheroma, residual thrombus, residual embolus, other
- Index procedure durations [Peri-procedural (by the end of the index procedure)]
Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Length of stay
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Time from end of procedure to discharge
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Incidence of same day discharge
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Incidence of next day discharge
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Incidence of ICU admission
- Characterize subject index procedure hospitalization course at discharge [Index procedure hospital admission to discharge, approximately 1 to 2 days]
Duration of ICU admission
- Primary vessel patency [30 days]
Determined by the investigator using DUS or ABI
- Rutherford class (if applicable) [Procedure to 30 days]
Improvement by at least one class at 30 days as compared to procedure
- Rutherford classification (if applicable) [Baseline, at hospital discharge (approximately 1-2 days), 30 days]
Characterize Rutherford classification
- Ankle Brachial Index (ABI) [Baseline to 30 days]
Change in ABI at 30 days compared to baseline.
- Incidence of device related arterial AEs [30 days]
Major bleeding (requiring transfusion) Arterial perforation Flow-limiting dissection (at the end of the procedure, prior to and following stenting, if performed) Distal embolization requiring surgical procedure or obstructing one of the major downstream vessels >70% (at the end of the procedure)
- Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR [30 days]
- Incidence of: Procedure-related SAEs Device-related (S)AEs [30 days]
- Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device [30 days]
- Incidence of index procedure access site complications [30 days]
Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs Numbness Other
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted
-
Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place
Exclusion Criteria:
- Subject is under the age of 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baton Rouge General Medical Center | Baton Rouge | Louisiana | United States | 70809 |
| 2 | Prisma Health Upstate | Greenville | South Carolina | United States | 29601 |
Sponsors and Collaborators
- SurModics, Inc.
Investigators
- Principal Investigator: Sean Lyden, MD, The Cleveland Clinic
- Principal Investigator: Joseph Campbell, MD, OhioHealth
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SUR22-001