Indigo Aspiration System for Acute Limb Ischemia
(STRIDE II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Indigo™ Aspiration System, a device designed to safely remove blood clots in individuals with lower limb acute ischemia, a condition where blood flow to the legs is suddenly reduced or blocked. The main goal is to gather evidence on the device's effectiveness and safety for patients. The trial seeks participants who have experienced symptoms for less than 14 days and have a confirmed blood vessel blockage in their legs, but no recent major leg amputation.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for the 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 team or your doctor.
What prior data suggests that the Indigo™ Aspiration System is safe for patients with lower extremity acute limb ischemia?
Research has shown that the Indigo Aspiration System is safe for treating sudden blood flow problems in the legs, known as lower extremity acute limb ischemia (LE ALI). In a study with 119 patients, the system effectively removed blood clots in 98.2% of cases and helped most patients maintain leg health within 30 days. Another report found that after one year, 88.5% of patients experienced good results, although 12 out of 100 patients passed away within that year. Overall, the Indigo Aspiration System is well-tolerated for this condition, with many patients experiencing positive outcomes.12345
Why are researchers excited about this trial?
The Indigo Aspiration System is unique because it uses a minimally invasive technique to remove clots from arteries in the legs, offering a different approach from the usual options like thrombolytic drugs or surgical procedures. This system uses aspiration, a method that acts like a vacuum to physically remove the clot quickly and effectively, which could mean faster relief of symptoms and potentially fewer complications. Researchers are excited because this system may provide an efficient alternative for patients who are not ideal candidates for more invasive methods, potentially improving outcomes and recovery times.
What evidence suggests that the Indigo Aspiration System is effective for lower extremity acute limb ischemia?
Research has shown that the Indigo™ Aspiration System, which participants in this trial will receive, effectively treats lower extremity acute limb ischemia (LE ALI), a condition affecting blood flow to the legs. Studies have found that it successfully saves the affected limb in 98.2% of cases. The system removes blood clots to restore blood flow. One study found that after one year, 88.5% of patients still had their limb intact, although there was a 12% death rate within that year. Overall, the Indigo system has demonstrated strong performance and safety in treating LE ALI.12345
Who Is on the Research Team?
Daniel Clair, MD
Principal Investigator
Vanderbilt University Medical Center
Dierk Scheinert, MD
Principal Investigator
Universitätsklinik Leipzig
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
Treatment
Participants undergo thrombus removal using the Indigo™ Aspiration System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Indigo Aspiration System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Device: Indigo Aspiration System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penumbra Inc.
Lead Sponsor
Citations
1.
penumbrainc.com
penumbrainc.com/new-data-demonstrates-indigo-aspiration-system-improves-ali-patient-outcomes/New Data Demonstrates Indigo Aspiration System ...
The primary endpoint of the study, target limb salvage, was achieved in 98.2% of patients. The Indigo system was able to achieve these high ...
Safety and efficacy of mechanical aspiration thrombectomy ...
Aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) ...
Penumbra Indigo Aspiration System Evaluated in 1-Year ...
As summarized in Penumbra's press release, the 1-year outcomes include an 88.5% target limb salvage rate and a 12% mortality rate at 365 days.
A Study of Patients With Lower Extremity Acute Limb ...
The primary objective of this study is to collect safety and performance data on the Indigo Aspiration System in a patient population with lower extremity acute ...
Safety and efficacy of mechanical aspiration thrombectomy ...
Key Findings: Aspiration thrombectomy in 119 participants with lower-extremity acute limb ischemia, resulted in 30-day target limb salvage rates ...
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