Pounce™ Thrombectomy System Retrospective Registry

Peripheral Arterial Disease Clinical Trial

— PROWL  

Official title:

Pounce™ Thrombectomy System Retrospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868161
• Other study ID #: SUR22-001
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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