Peripheral Arterial DiseasePROWLNCT05868161
Pounce™ Thrombectomy System Retrospective Registry
An observational study of Peripheral Arterial Disease and Acute Limb Ischemia, run by SurModics, Inc. at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Acute Limb Ischemia
- What is being tested?
- Pounce Thrombectomy System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 Apr 2023to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted
Who may be able to join
- 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
Who cannot join
- Subject is under the age of 18 years
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 7 recruiting
- Recruiting
Ascension Seton
Austin, Texas, 78723
- Recruiting
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Prisma Health Upstate
Greenville, South Carolina, 29601
- Completed
Allina Health
Minneapolis, Minnesota, 55407
- Completed
Community Hospital
Munster, Indiana, 46321
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
- Recruiting
OSF St. Francis Medical Center
Peoria, Illinois, 61637
- Recruiting
North Central Heart
Sioux Falls, South Dakota, 57108
About this study
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.
- Conditions
- Peripheral Arterial Disease, Acute Limb Ischemia
- Being tested
- Pounce Thrombectomy System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pounce Thrombectomy SystemDevice
Also called Mechanical thrombectomy
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | All subjects in whom the Pounce Thrombectomy System was attempted will be included. Receives: Device: Pounce Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician
Measured: 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)
Measured: Procedure to 30 days
Secondary outcomes (23)
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: Peri-procedural (by the end of the index procedure)
Index procedure durations
Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)
Measured: Peri-procedural (by the end of the index procedure)
Characterize subject index procedure hospitalization course at discharge
Length of stay
Measured: 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
Measured: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of same day discharge
Measured: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of next day discharge
Measured: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Incidence of ICU admission
Measured: Index procedure hospital admission to discharge, approximately 1 to 2 days
Characterize subject index procedure hospitalization course at discharge
Duration of ICU admission
Measured: Index procedure hospital admission to discharge, approximately 1 to 2 days
Primary vessel patency
Determined by the investigator using DUS or ABI
Measured: 30 days
Rutherford class (if applicable)
Improvement by at least one class at 30 days as compared to procedure
Measured: Procedure to 30 days
Rutherford classification (if applicable)
Characterize Rutherford classification
Measured: Baseline, at hospital discharge (approximately 1-2 days), 30 days
Ankle Brachial Index (ABI)
Change in ABI at 30 days compared to baseline.
Measured: 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)
Measured: 30 days
Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR
Measured: 30 days
Incidence of: Procedure-related SAEs Device-related (S)AEs
Measured: 30 days
Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start18 Apr 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurModics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Lyden, MD, Principal investigator, The Cleveland ClinicJoseph Campbell, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868161
- Sponsor's protocol ID
- SUR22-001
- Acronym
- PROWL
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pounce™ Thrombectomy System Retrospective Registry
- ClinicalTrials.gov ID
- NCT05868161
- Acronym / sponsor ID
- PROWL / SUR22-001
- Conditions
- Peripheral Arterial Disease, Acute Limb Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SurModics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Device: Pounce Thrombectomy SystemAll subjects in whom the Pounce Thrombectomy System was attempted will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Subject is under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pounce Thrombectomy SystemAlso: Mechanical thrombectomyNon-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System. | Device | Retrospective |
Primary outcome
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
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)
23 secondary outcomes
Technical success
Time frame: 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)
Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate
Time frame: 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)
Underlying atheroma stenosis
Time frame: Peri-procedural (by the end of the index procedure)
Describe index procedural characteristics
Time frame: Peri-procedural (by the end of the index procedure)
Adjunctive procedures
Time frame: Peri-procedural (by the end of the index procedure)
Index procedure durations
Time frame: 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
Characterize subject index procedure hospitalization course at discharge
Time frame: 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
Characterize subject index procedure hospitalization course at discharge
Time frame: 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
Characterize subject index procedure hospitalization course at discharge
Time frame: Index procedure hospital admission to discharge, approximately 1 to 2 days
Primary vessel patency
Time frame: 30 days
Rutherford class (if applicable)
Time frame: Procedure to 30 days
Rutherford classification (if applicable)
Time frame: Baseline, at hospital discharge (approximately 1-2 days), 30 days
Ankle Brachial Index (ABI)
Time frame: Baseline to 30 days
Incidence of device related arterial AEs
Time frame: 30 days
Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR
Time frame: 30 days
Incidence of: Procedure-related SAEs Device-related (S)AEs
Time frame: 30 days
Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device
Time frame: 30 days
Incidence of index procedure access site complications
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Lyden, MD principal investigator
The Cleveland Clinic
Joseph Campbell, MD principal investigator
OhioHealth
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Acute Limb Ischemia, run by SurModics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Program Manager (1-866-787-6639, PROWLRegistry@surmodics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Peri-procedural (by the end of the index procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.