FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
2026年8月5日 更新者：Penumbra Inc.
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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
観察的
入学 (推定)
250
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Madeline Turtle
- 電話番号：260-224-8231
- メール：MTurtle@PENUMBRAINC.COM
研究連絡先のバックアップ
- 名前：Jennifer Jelf
- 電話番号：510-440-5719
- メール：jjelf@penumbrainc.com
研究場所
-
-
Tennessee
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Knoxville、Tennessee、アメリカ、37916
- 募集
- Fort Sanders Regional Medical Center
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Participants experiencing acute ischemic stroke (AIS) due to a primary M2 occlusion in the vertical segment or post-bifurcation in the non-dominant or co-dominant branch of the horizontal segment.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Medical Management
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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.
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Endovascular Thrombectomy plus Medical Management
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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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in NIHSS at 24 hours
時間枠：24 hours
|
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination tool used to measure the severity of a stroke.
The scale ranges from 0 to 42, with higher scores indicating greater impairment.
|
24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
90-day Modified Rankin Scale (mRS)
時間枠：90 Days
|
The modified Rankin Scale (mRS) is used to measure the degree of disability or dependence in daily activities in people who have experienced a stroke.
Scores range from no symptoms (0) to death (6), with higher scores indicating greater severity.
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90 Days
|
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Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment
時間枠：Treatment/Procedure
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Treatment/Procedure
|
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90-day NIHSS
時間枠：90 Days
|
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination tool used to measure the severity of a stroke.
The scale ranges from 0 to 42, with higher scores indicating greater impairment.
|
90 Days
|
|
Quality of Life, as measured by Barthel Index
時間枠：90 Days
|
The Barthel Index is a 0-100 point scale used to measure a person's functional independence in daily activities.
The index rates 10 items, including feeding, bathing, grooming, dressing, bowel/bladder control, toilet use, transfers, mobility, and stair use.
Higher scores indicate greater independence, while lower scores signify higher dependency on caregivers.
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90 Days
|
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Quality of Life, as measured by Neuro-QoL
時間枠：90 Days
|
Neuro-QoL is a set of patient-reported outcome measures designed to assess health-related quality of life across physical, mental, and social domains relevant to individuals with neurological conditions.
It uses calibrated item banks and short forms to measure constructs such as mobility, cognitive function, emotional/behavioral health, fatigue, and social participation.
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90 Days
|
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Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS)
時間枠：90 Days
|
COSMOS is a 7-point scale ranging from 0 (no symptoms) to 6 (loss of independence for an instrumental or basic activity of daily living or worse), which accounts for performance limitations and losses of a person's hobbies or passions and of their employment, educational, service, or caregiving pursuits, besides just activities of daily living.
|
90 Days
|
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Safety events of interest
時間枠：Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
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Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
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|
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Treatment method per the physician's clinical judgment
時間枠：Baseline
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Baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alejandro Spiotta, MD、Medical University of South Carolina
- 主任研究者：Nitin Goyal, MD、University of Tennessee Health Science Center/Semmes Murphey Clinic
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月26日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年8月5日
最初の投稿 (実際)
2026年8月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月6日
QC基準を満たした最後の更新が送信されました
2026年8月5日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。