Pounce Thrombectomy System
DeviceNon-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Other names: Mechanical thrombectomy
NCT Number: NCT05868161
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
OSF St. Francis Medical Center, Peoria, Illinois, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Other names: Mechanical thrombectomy
Time frame: 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
Time frame: Procedure to 30 days
Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: Peri-procedural (by the end of the index procedure)
Number of passes of Pounce Thrombectomy System
Time frame: 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
Time frame: Peri-procedural (by the end of the index procedure)
Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Length of stay
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Time from end of procedure to discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Incidence of same day discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Incidence of next day discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Incidence of ICU admission
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Duration of ICU admission
Time frame: 30 days
Determined by the investigator using DUS or ABI
Time frame: Procedure to 30 days
Improvement by at least one class at 30 days as compared to procedure
Time frame: Baseline, at hospital discharge (approximately 1-2 days), 30 days
Characterize Rutherford classification
Time frame: Baseline to 30 days
Change in ABI at 30 days compared to baseline.
Time frame: 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)
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs
Contact information is provided by the study sponsor or research team.
SurModics, Inc.
Industry
Acronym: PROWL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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