FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Part of paid clinical trials in Knoxville, Tennessee.
- Sponsor
- Penumbra Inc.
- Study ID
- NCT07749170
- Status
- Recruiting
Conditions
- Acute Ischemic Stroke
- Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Endovascular Thrombectomy — DEVICEPatients will undergo endovascular thrombectomy plus medical management. Patients will be treated with the Penumbra System Reperfusion Catheters. Perioperative and postoperative management will follow established guidelines for the care of stroke patients.
- Medical Management — OTHERAll medical management treatment will follow established guidelines for the care of stroke patients. All medical treatments and supportive care will be administered following each participating hospital's routine practice and in accordance with the Instructions for Use for any medication administered.
Study Details
The objective of this study is to collect safety and effectiveness data on the Penumbra System reperfusion catheters in participants with isolated primary non-dominant and distal M2 occlusions who undergo endovascular mechanical thrombectomy (EVT). Additionally, this study aims to observe characteristics and outcomes of participants treated with medical management (MM) alone and those who receive EVT + MM per current medical practice.
Key Dates
- First listed
- Aug 6, 2026
- Start date
- Jun 26, 2026
- Status verified
- Jul 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 250 participants (estimated)
Arms
- Arm: Medical Management
- Arm: Endovascular Thrombectomy plus Medical Management
Primary Outcome Measure
Change in NIHSS at 24 hours [ Time Frame: 24 hours ]
Central Contacts
- Madeline Turtle260-224-8231
- Jennifer Jelf510-440-5719
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fort Sanders Regional Medical Center | Knoxville | Tennessee | 37916 | - |
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