Pounce™ Thrombectomy System Retrospective Registry (PROWL)

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 Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Acute Limb Ischemia
• Intervention / Treatment: Device: Pounce Thrombectomy System

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Clinical Program Manager; Phone Number: 1-866-787-6639; Email: PROWLRegistry@surmodics.com

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • OSF St. Francis Medical Center
  • Indiana
    • Munster, Indiana, United States, 46321
      • Completed
      • Community Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Baton Rouge General Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Completed
      • Allina Health
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Recruiting
      • Prisma Health Upstate
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • North Central Heart
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Ascension Seton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; All subjects in whom the Pounce Thrombectomy System was attempted will be included.	Device: Pounce Thrombectomy System; Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.; Other Names: Mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SurModics, Inc.
• Investigators: Principal Investigator: Sean Lyden, MD, The Cleveland Clinic; Principal Investigator: Joseph Campbell, MD, OhioHealth

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: SUR22-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No