Pounce™ Thrombectomy System Retrospective Registry

Recruiting

• Conditions: Peripheral Arterial Disease; Acute Limb Ischemia
• Interventions: Device: Pounce Thrombectomy System

• Registration Number: NCT05868161
• Lead Sponsor: SurModics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-06
• Study Start: 2023-04-18
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	Pounce Thrombectomy System	All subjects in whom the Pounce Thrombectomy System was attempted will be included.

Primary Outcome Measures

Name	Time	Method
Procedural Success	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
Incidence of device related Major Adverse Events (MAEs)	Procedure to 30 days	Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Primary vessel patency	30 days	Determined by the investigator using DUS or ABI
Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate	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.
Characterize subject index procedure hospitalization course at discharge	Index procedure hospital admission to discharge, approximately 1 to 2 days	Duration of ICU admission
Completeness of thromboemboli removal (by angiography)	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
Underlying atheroma stenosis	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
Modified Society for Vascular Surgery (SVS) runoff	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).
Describe index procedural characteristics	Peri-procedural (by the end of the index procedure)	Number of passes of Pounce Thrombectomy System; * Total number of passes; * Number of passes in each vessel
Adjunctive procedures	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
Rutherford classification (if applicable)	Baseline, at hospital discharge (approximately 1-2 days), 30 days	Characterize Rutherford classification
Incidence of index procedure access site complications	30 days	Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs; * Numbness; * Other
Technical success	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
Index procedure durations	Peri-procedural (by the end of the index procedure)	Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)
Incidence of: Procedure-related SAEs Device-related (S)AEs	30 days
Rutherford class (if applicable)	Procedure to 30 days	Improvement by at least one class at 30 days as compared to procedure
Ankle Brachial Index (ABI)	Baseline to 30 days	Change in ABI at 30 days compared to baseline.
Incidence of device related arterial AEs	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)
Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR	30 days
Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device	30 days

Trial Locations

Locations (9)

OSF St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Community Hospital; 🇺🇸 Munster, Indiana, United States

Baton Rouge General Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Allina Health; 🇺🇸 Minneapolis, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Prisma Health Upstate; 🇺🇸 Greenville, South Carolina, United States

North Central Heart; 🇺🇸 Sioux Falls, South Dakota, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Ascension Seton; 🇺🇸 Austin, Texas, United States