NCT05868161

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2023Jul 2026

First Submitted

Initial submission to the registry

April 6, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

April 6, 2023

Last Update Submit

September 4, 2025

Conditions

Peripheral Arterial DiseaseAcute Limb Ischemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (23)

  • Technical success

    Peri-procedural (by the end of the index procedure)

  • Completeness of thromboemboli removal (by angiography)

    Peri-procedural (by the end of the index procedure)

  • Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate

    Peri-procedural (by the end of the index procedure)

  • Modified Society for Vascular Surgery (SVS) runoff

    Pre-procedure, Peri-procedural (by the end of the index procedure)

  • Underlying atheroma stenosis

    Peri-procedural (by the end of the index procedure)

  • +18 more secondary outcomes

Study Arms (1)

Retrospective

All subjects in whom the Pounce Thrombectomy System was attempted will be included.

Device: Pounce Thrombectomy System

Interventions

Pounce Thrombectomy SystemDEVICE

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

Also known as: Mechanical thrombectomy
Retrospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Subject is under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Community Hospital

Munster, Indiana, 46321, United States

COMPLETED

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Allina Health

Minneapolis, Minnesota, 55407, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Prisma Health Upstate

Greenville, South Carolina, 29601, United States

RECRUITING

North Central Heart

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Ascension Seton

Austin, Texas, 78723, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Sean Lyden, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Joseph Campbell, MD

    OhioHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Program Manager

CONTACT

1-866-787-6639PROWLRegistry@surmodics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 22, 2023

Study Start

April 18, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

US(9)