Recruiting

Pounce™ Thrombectomy

Sponsor:

SurModics, Inc.

Code:

NCT05868161

Conditions

Peripheral Arterial Disease

Acute Limb Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pounce Thrombectomy System

Study Details

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.

Conditions

Peripheral Arterial Disease

Acute Limb Ischemia

Study ID

NCT05868161

Start date

Apr 18, 2023

Status verified date

Sep, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective

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

Interventions

Pounce Thrombectomy System

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

Primary outcome measure

  • Procedural Success [ Time Frame: Peri-procedural (by the end of the index procedure) ]
  • Incidence of device related Major Adverse Events (MAEs) [ Time Frame: Procedure to 30 days ]

Central Contacts and Locations

Central contacts

Clinical Program Manager

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

Locations

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Baton Rouge General Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Prisma Health Upstate

Recruiting

Greenville, South Carolina, United States, 29601

North Central Heart

Recruiting

Sioux Falls, South Dakota, United States, 57108

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Ascension Seton

Recruiting

Austin, Texas, United States, 78723

More Information

Sponsor

SurModics, Inc.

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SurModics, Inc. on 2025-09-11.