Recruiting NCT05868161
Pounce™ Thrombectomy System Retrospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pounce Thrombectomy System.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Acute Limb Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Pounce Thrombectomy System
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- OSF St. Francis Medical Center — Peoria
- Community Hospital — Munster
- Baton Rouge General Medical Center — Baton Rouge
- Allina Health — Minneapolis
- Cleveland Clinic — Cleveland
- Prisma Health Upstate — Greenville
- North Central Heart — Sioux Falls
- Vanderbilt University Medical Center — Nashville
- … and 1 more center
Identifiers
NCT: NCT05868161 · SUR22-001