Pounce Thrombectomy System for Peripheral Artery Disease
(PROWL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study the Pounce™ Thrombectomy System, a device designed to remove blood clots from arteries outside the heart. Researchers seek to evaluate the device's effectiveness in treating clots in peripheral arteries, which supply blood to the arms and legs, without surgery. Individuals who have undergone a procedure using the Pounce Thrombectomy System may be eligible to participate by sharing their past medical data for the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Surmodics™ Pounce™ Thrombectomy System is safe for non-surgical removal of emboli and thrombi?
Studies have shown that the Pounce™ Thrombectomy System is safe for patients. One study found no serious side effects or device-related problems, indicating no major safety issues. Another study demonstrated that the system successfully removed blood clots from arteries 83% of the time. This suggests it is both safe and effective for its intended use. Therefore, those considering joining a trial with this system can rely on current research supporting its safety.12345
Why are researchers excited about this trial?
The Pounce™ Thrombectomy System is unique because it offers a novel technique for removing blood clots. Unlike traditional treatments for thrombectomy, which often involve the use of medication to dissolve clots or mechanical devices that may require complex setups, the Pounce™ System is designed to physically retrieve clots more efficiently. Researchers are excited about this system because it potentially reduces procedure time and may improve outcomes by offering a more direct and minimally invasive approach to clot removal. This could lead to faster recovery times and better overall success rates for patients suffering from thrombosis.
What evidence suggests that the Pounce Thrombectomy System is effective for removing emboli and thrombi in the peripheral arterial vasculature?
Research has shown that the Pounce Thrombectomy System effectively removes blood clots from arteries outside the heart. In a study with 160 patients, it successfully cleared clots 83% of the time. The process typically takes about 24 minutes and often requires two attempts per patient. This device is primarily used in arteries that are 3.5 to 6 millimeters wide. These results suggest that the Pounce Thrombectomy System is a reliable option for treating blood clots in these arteries. Participants in this trial will be included in a retrospective analysis of cases where the Pounce Thrombectomy System was attempted.12467
Who Is on the Research Team?
Sean Lyden, MD
Principal Investigator
The Cleveland Clinic
Joseph Campbell, MD
Principal Investigator
OhioHealth
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Retrospective Data Collection
Data is collected retrospectively from subjects in whom the Pounce Thrombectomy System was attempted
Follow-up
Participants are monitored for safety and effectiveness after the index procedure
What Are the Treatments Tested in This Trial?
Interventions
- Pounce Thrombectomy System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects in whom the Pounce Thrombectomy System was attempted will be included.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SurModics, Inc.
Lead Sponsor
Citations
1.
surmodics.gcs-web.com
surmodics.gcs-web.com/news-releases/news-release-details/surmodics-announces-outcomes-160-patients-prowl-registryNews Release - Surmodics, Inc.
Average Pounce Platform use time in the study was 24.1 minutes with a median of 2 passes per patient. Core lab adjudicated procedural thrombus ...
Pounce™ Thrombectomy System
The Pounce ™ Thrombectomy Platform allowed for significant efficacy with high procedural success.1.
Clinical Data
Results from a prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute vein thrombosis followed to 12 months.
4.
nasdaq.com
nasdaq.com/press-release/surmodics-announces-outcomes-160-patients-prowl-registry-evaluating-pouncetmSurmodics Announces Outcomes from 160 Patients in ...
Most patients in the subset were treated with the Pounce Thrombectomy System, indicated for use in peripheral arteries 3.5-6 mm in diameter. The ...
5.
evtoday.com
evtoday.com/articles/2023-dec-supplement/preliminary-clinical-evidence-on-pounce-thrombectomy-system-performancePreliminary Clinical Evidence on Pounce™ Thrombectomy ...
We achieved 83% technical success in effectively removing thrombus from the peripheral arterial segments where the Pounce™ System was used.* This is ...
June 12, 2023 Surmodics Inc. Holly Ramirez Senior Staff ...
The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter. Type of Use (Select one or both, as ...
Pounce Thrombectomy System to Treat Acute and Chronic ...
PTS coupled with PTA/stenting is expeditiously safe and effective in patients with thrombus-associated lower limb occlusion. Previous article in issue; Next ...
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