Pounce™ Thrombectomy System Retrospective Registry (PROWL)

September 4, 2025 updated by: SurModics, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Peri-procedural (by the end of the index procedure)
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)
Procedure to 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Peri-procedural (by the end of the index procedure)
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
Peri-procedural (by the end of the index procedure)
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.
Peri-procedural (by the end of the index procedure)
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).
Pre-procedure, Peri-procedural (by the end of the index procedure)
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
Peri-procedural (by the end of the index procedure)
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
Peri-procedural (by the end of the index procedure)
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
Peri-procedural (by the end of the index procedure)
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)
Peri-procedural (by the end of the index procedure)
Characterize subject index procedure hospitalization course at discharge
Time Frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Length of stay
Index procedure hospital admission to discharge, approximately 1 to 2 days
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
Index procedure hospital admission to discharge, approximately 1 to 2 days
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
Index procedure hospital admission to discharge, approximately 1 to 2 days
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
Index procedure hospital admission to discharge, approximately 1 to 2 days
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
Index procedure hospital admission to discharge, approximately 1 to 2 days
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
Index procedure hospital admission to discharge, approximately 1 to 2 days
Primary vessel patency
Time Frame: 30 days
Determined by the investigator using DUS or ABI
30 days
Rutherford class (if applicable)
Time Frame: Procedure to 30 days
Improvement by at least one class at 30 days as compared to procedure
Procedure to 30 days
Rutherford classification (if applicable)
Time Frame: Baseline, at hospital discharge (approximately 1-2 days), 30 days
Characterize Rutherford classification
Baseline, at hospital discharge (approximately 1-2 days), 30 days
Ankle Brachial Index (ABI)
Time Frame: Baseline to 30 days
Change in ABI at 30 days compared to baseline.
Baseline to 30 days
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)
30 days
Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR
Time Frame: 30 days
30 days
Incidence of: Procedure-related SAEs Device-related (S)AEs
Time Frame: 30 days
30 days
Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device
Time Frame: 30 days
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SurModics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Lyden, MD, The Cleveland Clinic
  • Principal Investigator: Joseph Campbell, MD, OhioHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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