Pounce™ Thrombectomy System Retrospective Registry

Study Overview
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Brief Summary
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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.

Official Title
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Pounce™ Thrombectomy System Retrospective Registry

Conditions
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Peripheral Arterial Disease, Acute Limb Ischemia

Intervention / Treatment
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* Device: Pounce Thrombectomy System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>All subjects in whom the Pounce Thrombectomy System was attempted will be included. | Device: Pounce Thrombectomy System<br>* Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.<br>* Other names: Mechanical thrombectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician | Peri-procedural (by the end of the index procedure) | 
| Incidence of device related Major Adverse Events (MAEs) | Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR) | Procedure to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | 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 | Peri-procedural (by the end of the index procedure) | 
| Completeness of thromboemboli removal (by angiography) | Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician | Peri-procedural (by the end of the index procedure) | 
| Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate | TIPI flow rate at the end of thrombectomy procedure and after any adjunctive procedures as determined by the core lab and physician. | Peri-procedural (by the end of the index procedure) | 
| Modified Society for Vascular Surgery (SVS) runoff | Pre-procedure vs. post-procedure runoff using a modified SVS runoff score as determined by the core lab and physician (if applicable). | Pre-procedure, Peri-procedural (by the end of the index procedure) | 
| Underlying atheroma stenosis | Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician | Peri-procedural (by the end of the index procedure) | 
| Describe index procedural characteristics | Number of passes of Pounce Thrombectomy System Total number of passes Number of passes in each vessel | Peri-procedural (by the end of the index procedure) | 
| Adjunctive procedures | Percentage of subjects in whom adjunctive procedures were performed ▪ Treatment for: underlying atheroma, residual thrombus, residual embolus, other | Peri-procedural (by the end of the index procedure) | 
| Index procedure durations | Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes) | Peri-procedural (by the end of the index procedure) | 
| Characterize subject index procedure hospitalization course at discharge | Length of stay | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Characterize subject index procedure hospitalization course at discharge | Time from end of procedure to discharge | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Characterize subject index procedure hospitalization course at discharge | Incidence of same day discharge | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Characterize subject index procedure hospitalization course at discharge | Incidence of next day discharge | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Characterize subject index procedure hospitalization course at discharge | Incidence of ICU admission | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Characterize subject index procedure hospitalization course at discharge | Duration of ICU admission | Index procedure hospital admission to discharge, approximately 1 to 2 days | 
| Primary vessel patency | Determined by the investigator using DUS or ABI | 30 days | 
| Rutherford class (if applicable) | Improvement by at least one class at 30 days as compared to procedure | Procedure to 30 days | 
| Rutherford classification (if applicable) | Characterize Rutherford classification | Baseline, at hospital discharge (approximately 1-2 days), 30 days | 
| Ankle Brachial Index (ABI) | Change in ABI at 30 days compared to baseline. | Baseline to 30 days | 
| Incidence of device related arterial AEs | 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) | 30 days | 
| 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 | Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs Numbness Other | 30 days |