Registry for the Pounce Thrombectomy System in treating blood clots
Pounce™ Thrombectomy System Retrospective Registry
SurModics, Inc. · NCT05868161
This study looks at how well the Pounce Thrombectomy System works for removing blood clots in patients with peripheral artery disease and acute limb ischemia who have had a specific procedure done.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SurModics, Inc. (industry) |
| Locations | 9 sites (Peoria, Illinois and 8 other locations) |
| Trial ID | NCT05868161 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data on the use of the Pounce Thrombectomy System, which is designed for the non-surgical removal of blood clots in patients with peripheral arterial disease and acute limb ischemia. The study involves multiple centers across the United States and focuses on patients who have undergone an endovascular intervention where this system was attempted. By analyzing the outcomes of these procedures, the registry aims to provide insights into the effectiveness and safety of the Pounce system.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients who have undergone an endovascular intervention involving the Pounce Thrombectomy System and can provide informed consent.
Not a fit: Patients under the age of 18 years will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this registry could enhance treatment options for patients suffering from peripheral arterial disease and improve outcomes related to blood clot removal.
How similar studies have performed: While this registry is focused on a specific device, similar observational studies have shown success in evaluating the effectiveness of thrombectomy systems in treating vascular conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Peoria, Illinois and 8 other locations
- OSF St. Francis Medical Center — Peoria, Illinois, United States (RECRUITING)
- Community Hospital — Munster, Indiana, United States (COMPLETED)
- Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States (RECRUITING)
- Allina Health — Minneapolis, Minnesota, United States (COMPLETED)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Prisma Health Upstate — Greenville, South Carolina, United States (RECRUITING)
- North Central Heart — Sioux Falls, South Dakota, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- Ascension Seton — Austin, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Sean Lyden, MD — The Cleveland Clinic
- Study coordinator: Clinical Program Manager
- Email: PROWLRegistry@surmodics.com
- Phone: 1-866-787-6639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, Acute Limb Ischemia