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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05868161
Other study ID # SUR22-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2023
Est. completion date July 31, 2025

Study information

Verified date April 2024
Source SurModics, Inc.
Contact Clinical Program Manager
Phone 1-866-787-6639
Email PROWLRegistry@surmodics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date July 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Pounce Thrombectomy System
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.

Locations

Country Name City State
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Cleveland Clinic Cleveland Ohio
United States Prisma Health Upstate Greenville South Carolina
United States Allina Health Minneapolis Minnesota
United States Community Hospital Munster Indiana
United States Vanderbilt University Medical Center Nashville Tennessee
United States OSF St. Francis Medical Center Peoria Illinois
United States North Central Heart Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
SurModics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Index procedure durations Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes) Peri-procedural (by the end of the index procedure)
Secondary Characterize subject index procedure hospitalization course at discharge Length of stay Index procedure hospital admission to discharge, approximately 1 to 2 days
Secondary 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
Secondary Characterize subject index procedure hospitalization course at discharge Incidence of same day discharge Index procedure hospital admission to discharge, approximately 1 to 2 days
Secondary Characterize subject index procedure hospitalization course at discharge Incidence of next day discharge Index procedure hospital admission to discharge, approximately 1 to 2 days
Secondary Characterize subject index procedure hospitalization course at discharge Incidence of ICU admission Index procedure hospital admission to discharge, approximately 1 to 2 days
Secondary Characterize subject index procedure hospitalization course at discharge Duration of ICU admission Index procedure hospital admission to discharge, approximately 1 to 2 days
Secondary Primary vessel patency Determined by the investigator using DUS or ABI 30 days
Secondary Rutherford class (if applicable) Improvement by at least one class at 30 days as compared to procedure Procedure to 30 days
Secondary Rutherford classification (if applicable) Characterize Rutherford classification Baseline, at hospital discharge (approximately 1-2 days), 30 days
Secondary Ankle Brachial Index (ABI) Change in ABI at 30 days compared to baseline. Baseline to 30 days
Secondary 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
Secondary Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR 30 days
Secondary Incidence of: Procedure-related SAEs Device-related (S)AEs 30 days
Secondary Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device 30 days
Secondary 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
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