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NCT Number: NCT05868161

Pounce™ Thrombectomy System Retrospective Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OSF St. Francis Medical Center, Peoria, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pounce Thrombectomy System

Device

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

Other names: Mechanical thrombectomy

Primary outcomes

  1. Procedural Success

    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

  2. Incidence of device related Major Adverse Events (MAEs)

    Time frame: Procedure to 30 days

    Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)

Secondary outcomes

  1. Technical success

    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

  2. Completeness of thromboemboli removal (by angiography)

    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

  3. Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate

    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.

  4. Modified Society for Vascular Surgery (SVS) runoff

    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).

  5. Underlying atheroma stenosis

    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

  6. Describe index procedural characteristics

    Time frame: 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
  7. Adjunctive procedures

    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

  8. Index procedure durations

    Time frame: Peri-procedural (by the end of the index procedure)

    Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)

  9. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Length of stay

  10. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Time from end of procedure to discharge

  11. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Incidence of same day discharge

  12. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Incidence of next day discharge

  13. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Incidence of ICU admission

  14. Characterize subject index procedure hospitalization course at discharge

    Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days

    Duration of ICU admission

  15. Primary vessel patency

    Time frame: 30 days

    Determined by the investigator using DUS or ABI

  16. Rutherford class (if applicable)

    Time frame: Procedure to 30 days

    Improvement by at least one class at 30 days as compared to procedure

  17. Rutherford classification (if applicable)

    Time frame: Baseline, at hospital discharge (approximately 1-2 days), 30 days

    Characterize Rutherford classification

  18. Ankle Brachial Index (ABI)

    Time frame: Baseline to 30 days

    Change in ABI at 30 days compared to baseline.

  19. Incidence of device related arterial AEs

    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)

  20. Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR

    Time frame: 30 days

  21. Incidence of: Procedure-related SAEs Device-related (S)AEs

    Time frame: 30 days

  22. Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device

    Time frame: 30 days

  23. Incidence of index procedure access site complications

    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

    • Numbness
    • Other

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Program Manager

CONTACT

[email protected]

1-866-787-6639

Sponsors and collaborators

Lead sponsor

SurModics, Inc.

Industry

Registry information

Acronym: PROWL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 22, 2023
Registry last updated
Sep 11, 2025

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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