Boomerang Catheter for Critical Limb Ischemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called the Boomerang Catheter for individuals with severe leg artery blockages, known as Chronic Limb-Threatening Ischemia (CLTI). The catheter improves blood flow in the legs when other surgical options are unavailable. It suits adults who have been advised that no other surgical options exist and who experience severe blood flow issues in their legs. Participants should also belong to a wound care network and have stable wounds.
As an unphased trial, this study provides patients a unique opportunity to explore innovative treatment options when conventional surgeries are not viable.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have a known contraindication (reason not to use) to aspirin, certain blood thinners, or anticoagulants. It's best to discuss your current medications with the trial team.
What prior data suggests that the Boomerang Catheter is safe for percutaneous Deep Venous Arterialization?
Research has shown that the Boomerang Catheter demonstrates promising safety results from earlier studies. A review of similar procedures, such as percutaneous Deep Venous Arterialization (pDVA), found a high success rate of 96.2% and a survival rate of 82.8%, indicating that the procedure is generally well-tolerated. Although specific data on side effects for the Boomerang Catheter itself is lacking, the high success and survival rates provide some reassurance about its safety for treating chronic limb-threatening ischemia.12345
Why are researchers excited about this trial?
The Boomerang Catheter is unique because it offers a minimally invasive approach to treating critical limb ischemia, a condition that often relies on more invasive surgeries or long-term medication management. Unlike traditional methods like bypass surgery or angioplasty, the Boomerang Catheter is designed to precisely target and open blocked arteries in the limbs, potentially improving blood flow more directly and with fewer complications. Researchers are excited about this treatment because it could reduce recovery times and hospital stays, making it a promising option for patients who are at high risk for surgical procedures.
What evidence suggests that the Boomerang Catheter is effective for treating Chronic Limb-Threatening Ischemia?
Research shows that the Boomerang Catheter, which participants in this trial will receive, holds promise for treating severe blood flow problems in the limbs. It has improved blood circulation in complex procedures. A study that combined results from different trials found a high success rate of 96.2% with similar treatments, and an overall survival rate of 82.8%. These findings suggest it could effectively restore blood flow to limbs when other treatments have failed. The catheter redirects blood flow to enhance circulation in the affected limb.13678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 with Critical Limb-Threatening Ischemia who can't be helped by standard treatments. They must have a clear vein suitable for the procedure, controlled diabetes if applicable, and agree to potential minor amputation. Those with significant artery blockage or conditions that rule out this treatment are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA)
Follow-up
Participants are monitored for safety and effectiveness, including wound healing and limb salvage
What Are the Treatments Tested in This Trial?
Interventions
- Boomerang Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aveera Medical, Inc.
Lead Sponsor