Recruiting

EVT with MM

Sponsor:

Penumbra Inc.

Code:

NCT07749170

Conditions

Acute Ischemic Stroke

Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular Thrombectomy

Medical Management

Study Details

Brief summary:

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.

Conditions

Acute Ischemic Stroke

Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Study ID

NCT07749170

Start date

Jun 26, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participant age ≥ 18
2. Participant experiencing acute ischemic stroke due to a confirmed primary M2 occlusion in the vertical segment or post-bifurcation in the non-dominant or co-dominant branch of the horizontal segment
3. NIHSS ≥5 or NIHSS 3-4 with disabling symptoms
4. Pre-stroke mRS 0-1
5. For participants undergoing thrombectomy: Planned first-line treatment with Penumbra System reperfusion catheters
6. Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Exclusion Criteria:

1. Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period.
2. Known multiple occlusions
3. Secondary M2 occlusion
4. Known or high suspicion of underlying ICAD as the cause of the M2 occlusion
5. Current hospitalization at time of stroke onset and/or any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
6. Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment. Participants in secondary prevention, observational, natural history and/or epidemiological studies are eligible.
7. Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Medical Management

Endovascular Thrombectomy plus Medical Management

Interventions

Endovascular Thrombectomy

Patients 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

All 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.

Primary outcome measure

  • Change in NIHSS at 24 hours [ Time Frame: 24 hours ]

Central Contacts and Locations

Locations

Fort Sanders Regional Medical Center

Recruiting

Knoxville, Tennessee, United States, 37916

More Information

Sponsor

Penumbra Inc.

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Penumbra Inc. on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.