Clinical trial NCT05868161: Pounce™ Thrombectomy System Retrospective Registry
Official title: Pounce™ Thrombectomy System Retrospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Acute Limb Ischemia
Lead sponsor: SurModics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted

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.


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

Primary outcomes:
measure: Procedural Success
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Incidence of device related Major Adverse Events (MAEs)
timeFrame: Procedure to 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Completeness of thromboemboli removal (by angiography)
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Modified Society for Vascular Surgery (SVS) runoff
timeFrame: Pre-procedure, Peri-procedural (by the end of the index procedure)
measure: Underlying atheroma stenosis
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Describe index procedural characteristics
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Adjunctive procedures
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Index procedure durations
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Characterize subject index procedure hospitalization course at discharge
timeFrame: Index procedure hospital admission to discharge, approximately 1 to 2 days
measure: Primary vessel patency
timeFrame: 30 days
measure: Rutherford class (if applicable)
timeFrame: Procedure to 30 days
measure: Rutherford classification (if applicable)
timeFrame: Baseline, at hospital discharge (approximately 1-2 days), 30 days
measure: Ankle Brachial Index (ABI)
timeFrame: Baseline to 30 days
measure: Incidence of device related arterial AEs
timeFrame: 30 days
measure: Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR
timeFrame: 30 days
measure: Incidence of: Procedure-related SAEs Device-related (S)AEs
timeFrame: 30 days
measure: Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device
timeFrame: 30 days
measure: Incidence of index procedure access site complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Minneapolis
country: United States
facility: Allina Health
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OhioHealth
name: Joseph Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: