Pounce™ Thrombectomy System Retrospective Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSurModics, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subject is under the age of 18 years
Trial population
Adult subjects who have had an endovascular intervention where use of the Pounce Thrombectomy System was attempted
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Pounce Thrombectomy System
DeviceNon-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Retrospective1 intervention
Trial outcomes
Primary outcomes
1
Procedural Success
Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician
Time frame
Peri-procedural (by the end of the index procedure)2
Incidence of device related Major Adverse Events (MAEs)
Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)
Time frame
Procedure to 30 daysSecondary outcomes
1
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
Time frame
Peri-procedural (by the end of the index procedure)2
Completeness of thromboemboli removal (by angiography)
Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician
Time frame
Peri-procedural (by the end of the index procedure)3
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.
Time frame
Peri-procedural (by the end of the index procedure)4
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).
Time frame
Pre-procedure, Peri-procedural (by the end of the index procedure)Sponsors and contacts
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Source ClinicalTrials.gov