Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
Launched by PENUMBRA INC. · Jun 4, 2024
Trial Information
Current as of February 12, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the INDIGO Aspiration System, a device used to treat serious blood flow problems in the legs and abdomen, such as sudden blockages in the arteries or severe blood clots. The goal is to find out how safe and effective this system is for patients who need urgent treatment for these conditions. Researchers are collecting important information on how well the device works and any potential risks involved.
To participate in this trial, patients must meet specific criteria based on local Japanese guidelines for treating these conditions. This includes having acute problems in the arteries of the lower limbs or abdomen or severe deep vein thrombosis in the legs. There are certain criteria that would exclude patients from participating if they do not meet these guidelines. For those who are eligible, the process will involve using the INDIGO system as part of their treatment, and they will be monitored closely for their health outcomes. Overall, this trial is important for understanding how this new treatment can benefit patients facing these serious medical issues.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
- Exclusion Criteria:
- • Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
About Penumbra Inc.
Penumbra Inc. is a leading medical technology company focused on developing innovative solutions for neurovascular and peripheral vascular conditions. With a commitment to advancing patient care, Penumbra specializes in the design and manufacture of devices that enhance the treatment of complex medical conditions, including stroke and embolism. The company leverages cutting-edge technology and rigorous clinical research to deliver products that improve outcomes and enhance the quality of life for patients. Penumbra's dedication to innovation and collaboration with healthcare professionals positions it at the forefront of the medical device industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nara, , Japan
Alameda, California, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0