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.
Study Type
OBSERVATIONAL
Enrollment
500
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
OSF St. Francis Medical Center
Peoria, Illinois, United States
RECRUITINGCommunity Hospital
Munster, Indiana, United States
COMPLETEDBaton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Procedural Success
Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician
Time frame: 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)
Time frame: Procedure to 30 days
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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Pre-procedure, Peri-procedural (by the end of the index procedure)
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Allina Health
Minneapolis, Minnesota, United States
COMPLETEDCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGPrisma Health Upstate
Greenville, South Carolina, United States
RECRUITINGNorth Central Heart
Sioux Falls, South Dakota, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGAscension Seton
Austin, Texas, United States
RECRUITINGUnderlying atheroma stenosis
Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician
Time frame: 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
Time frame: 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
Time frame: Peri-procedural (by the end of the index procedure)
Index procedure durations
Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)
Time frame: Peri-procedural (by the end of the index procedure)
Characterize subject index procedure hospitalization course at discharge
Length of stay
Time frame: 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
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of same day discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of next day discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of ICU admission
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Duration of ICU admission
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Primary vessel patency
Determined by the investigator using DUS or ABI
Time frame: 30 days
Rutherford class (if applicable)
Improvement by at least one class at 30 days as compared to procedure
Time frame: Procedure to 30 days
Rutherford classification (if applicable)
Characterize Rutherford classification
Time frame: Baseline, at hospital discharge (approximately 1-2 days), 30 days
Ankle Brachial Index (ABI)
Change in ABI at 30 days compared to baseline.
Time frame: 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)
Time frame: 30 days
Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR
Time frame: 30 days
Incidence of: Procedure-related SAEs Device-related (S)AEs
Time frame: 30 days
Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device
Time frame: 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
Time frame: 30 days