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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | All subjects in whom the Pounce Thrombectomy System was attempted will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pounce Thrombectomy System | Device | Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Manager | Contact | 1-866-787-6639 | PROWLRegistry@surmodics.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Lyden, MD | The Cleveland Clinic | Principal Investigator |
| Joseph Campbell, MD | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSF St. Francis Medical Center | Recruiting | Peoria | Illinois | 61637 | United States | |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
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
| 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
| 30 days |
| Community Hospital |
| Completed |
| Munster |
| Indiana |
| 46321 |
| United States |
| Baton Rouge General Medical Center | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Allina Health | Completed | Minneapolis | Minnesota | 55407 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Prisma Health Upstate | Recruiting | Greenville | South Carolina | 29601 | United States |
| North Central Heart | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
| Ascension Seton | Recruiting | Austin | Texas | 78723 | United States |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |