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Recruiting NCT07749170

FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions

— Observational Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular Thrombectomy, Medical Management.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

FORWARD is a prospective, multicenter, observational study that will be conducted internationally.

Participants who satisfy all inclusion criteria and none of the exclusion criteria will be eligible for enrollment. They will receive treatment according to the physicians' clinical judgement per standard of care at their institution.

Interventions

  • Device 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.
  • Other 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 measures

  • Change in NIHSS at 24 hours [Time frame: 24 hours]
Secondary outcome measures (8)
  • 90-day Modified Rankin Scale (mRS) [Time frame: 90 Days]
  • Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment [Time frame: Treatment/Procedure]
  • 90-day NIHSS [Time frame: 90 Days]
  • Quality of Life, as measured by Barthel Index [Time frame: 90 Days]
  • Quality of Life, as measured by Neuro-QoL [Time frame: 90 Days]
  • Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS) [Time frame: 90 Days]
  • Safety events of interest [Time frame: Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days]
  • Treatment method per the physician's clinical judgment [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Participant age ≥ 18
  • 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
  • NIHSS ≥5 or NIHSS 3-4 with disabling symptoms
  • Pre-stroke mRS 0-1
  • For participants undergoing thrombectomy: Planned first-line treatment with Penumbra System reperfusion catheters
  • Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Exclusion criteria

  • Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period.
  • Known multiple occlusions
  • Secondary M2 occlusion
  • Known or high suspicion of underlying ICAD as the cause of the M2 occlusion
  • 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
  • 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Fort Sanders Regional Medical Center — Knoxville

Identifiers

NCT: NCT07749170 · 33727

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗