Acute Limb Ischemia, Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEPounce Thrombectomy System
Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.
Sponsors
SurModics, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Peri-procedural (by the end of the index procedure) | Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician |
| Incidence of device related Major Adverse Events (MAEs) | Procedure to 30 days | Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate | Peri-procedural (by the end of the index procedure) | TIPI flow rate at the end of thrombectomy procedure and after any adjunctive procedures as determined by the core lab and physician. |
| Modified Society for Vascular Surgery (SVS) runoff | Pre-procedure, Peri-procedural (by the end of the index procedure) | Pre-procedure vs. post-procedure runoff using a modified SVS runoff score as determined by the core lab and physician (if applicable). |
| Underlying atheroma stenosis | Peri-procedural (by the end of the index procedure) | Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician |
| Describe index procedural characteristics | Peri-procedural (by the end of the index procedure) | Number of passes of Pounce Thrombectomy System * Total number of passes * Number of passes in each vessel |
| Adjunctive procedures | Peri-procedural (by the end of the index procedure) | Percentage of subjects in whom adjunctive procedures were performed ▪ Treatment for: underlying atheroma, residual thrombus, residual embolus, other |
| Index procedure durations | Peri-procedural (by the end of the index procedure) | Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes) |
| Characterize subject index procedure hospitalization course at discharge | Index procedure hospital admission to discharge, approximately 1 to 2 days | Length of stay |
| Primary vessel patency | 30 days | Determined by the investigator using DUS or ABI |
| Technical success | Peri-procedural (by the end of the index procedure) | 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 |
| Rutherford classification (if applicable) | Baseline, at hospital discharge (approximately 1-2 days), 30 days | Characterize Rutherford classification |
| Ankle Brachial Index (ABI) | Baseline to 30 days | Change in ABI at 30 days compared to baseline. |
| Incidence of device related arterial AEs | 30 days | Major bleeding (requiring transfusion) Arterial perforation Flow-limiting dissection (at the end of the procedure, prior to and following stenting, if performed) Distal embolization requiring surgical procedure or obstructing one of the major downstream vessels \>70% (at the end of the procedure) |
| Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR | 30 days | — |
| Incidence of: Procedure-related SAEs Device-related (S)AEs | 30 days | — |
| Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device | 30 days | — |
| Incidence of index procedure access site complications | 30 days | Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs * Numbness * Other |
| Rutherford class (if applicable) | Procedure to 30 days | Improvement by at least one class at 30 days as compared to procedure |
| Completeness of thromboemboli removal (by angiography) | Peri-procedural (by the end of the index procedure) | Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician |
Countries
United States
Contacts
Primary ContactClinical Program Manager
Outcome results
None listed