i-RISE: International Acute Ischemic Stroke Study With the Penumbra System®
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• I.1. Patient age 18-75 years
• I.2. Pre-stroke mRS 0-1
• I.3. Patients experiencing acute ischemic stroke who are eligible for mechanical thrombectomy using the Penumbra System
• I.4. Frontline treatment with Penumbra System
• I.5. Signed informed consent per Institution Review Board/Ethics Committee
Locations
Other Locations
Australia
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU de Brest - Hôpital de la Cavale Blanche
RECRUITING
Brest
Hôpital Pierre-Paul Riquet
RECRUITING
Toulouse
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
RECRUITING
Lübeck
Knappschaft Kliniken Vest Recklinghausen
RECRUITING
Recklinghausen
Switzerland
Universitätsspital Basel
RECRUITING
Basel
Inselspital Universitätsklinik für Neurologie
RECRUITING
Bern
Contact Information
Primary
Celina Wang
cwang1@penumbrainc.com
+49 175 1938 209
Backup
Jennifer Jelf
jjelf@penumbrainc.com
+1 949 910 5357
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Patients with acute ischemic stroke (AIS)
Device: Penumbra System®
Related Therapeutic Areas
Sponsors
Leads: Penumbra Inc.