Stroke, IschemicLOTUSNCT04157270
LOTUS: Global Acute Stroke Study Utilizing Penumbra System
An observational study of Stroke, Ischemic, run by Penumbra Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Penumbra System
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2020to 10 May 2021
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Who may be able to join
- Patient age ≥ 18 and ≤ 85
- Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
- Planned frontline treatment with aspiration utilizing Penumbra System
- Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
- National Institute of Health Stroke Scale (NIHSS) ≥ 6
- Signed informed consent per Institution Review Board/Ethics Committee
- CT ASPECT score from 6 to 10 (≥ 6) or according to MR DWI ASPECT score from 5 to 10 (≥ 5)
- Pre-stroke mRS 0-1
Who cannot join
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- Associated myocardial infarction or severe infection (endocarditis or sepsis)
- Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) or > 3.0 or platelets count < 40 x 10^9/L or PTT/APTT > 50 sec
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
- Baseline glucose < 2.7 or > 22.2 mmol/L
- Seizure at the onset of stroke
Show all 15Show fewer
- Time of stroke symptom onset unknown
- Females who are pregnant
- Known serious sensitivity to radiographic contrast media that cannot be pre-treated
- Renal failure as defined by serum creatinine > 3.0mg/dl (264 µmol/L)
- Currently participating in an investigational (drug, device, etc.) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- CT/MRI evidence of the following conditions at screening: significant mass effect with midline shift, evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM), or intracranial tumor
- . Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
- Angiographic evidence of occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories
- Excessive arterial tortuosity that would prevent the device from reaching the target vessel
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RIA
Englewood, Colorado, 80113
Tampa General Hospital/USF
Tampa, Florida, 33606
About this study
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
- Conditions
- Stroke, Ischemic
- Being tested
- Penumbra System
- Keywords
- Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra SystemDevice
Penumbra System
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke | Patients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) Receives: Device: Penumbra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
mTICI Score
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
Measured: Immediate Post Procedure
Functional Subject Outcome
Good functional subject outcome at 90 days post-procedure as defined by modified Rankin Scale (mRS) 0-2. mRS scale from from 0 to 6 with higher values representing a worse outcome.
Measured: 90 days post
All-cause mortality at 90 days
All-cause mortality at 90 days
Measured: 90 days
Secondary outcomes (8)
Safety: Device and procedure related SAE
Incidence of device and procedure related Serious Adverse Events (SAEs)
Measured: Up to 30 days Post Procedure
Safety: Occurrence of ENT
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Measured: Immediate Post Procedure
Safety: Occurrence of Symptomatic intracranial hemorrhage
Occurrence of symptomatic hemorrhages (sICH) at 24 hours
Measured: Up to 24 Hours Post Procedure
Procedural Time
Time from the arterial puncture to revascularization defined by mTICI 2b or greater
Measured: Immediate Post Procedure
Stroke Onset to Revascularization
Time from stroke onset to revascularization defined by mTICI 2b or greater
Measured: Immediate Post Procedure
Complete Revascularization
Complete revascularization, defined as mTICI 2c and 3
Measured: Immediate Post Procedure
Length of index hospital stay
Measured: Up to 90 days Post Procedure
Type of Discharge Facility
Measured: Up to 90 days Post Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start12 Jan 2020
- Primary completion10 May 2021
- Study completion10 May 2021
Why it stopped: Business decision to focus on other studies. No safety concern
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157270
- Sponsor's protocol ID
- CLP 14788
- Acronym
- LOTUS
- Status last verified
- Jun 2021
- First submitted
- 4 Oct 2019
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOTUS: Global Acute Stroke Study Utilizing Penumbra System
- ClinicalTrials.gov ID
- NCT04157270
- Acronym / sponsor ID
- LOTUS / CLP 14788
- Conditions
- Stroke, Ischemic
- Keywords
- Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision to focus on other studies. No safety concern
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke | – | Device: Penumbra SystemPatients with acute ischemic stroke secondary to intracranial large vessel occlusion (LVO) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Key inclusion criteria (8 listed)
- Patient age ≥ 18 and ≤ 85
- Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
- Planned frontline treatment with aspiration utilizing Penumbra System
- Present with symptoms consistent with an acute ischemic stroke within 8 hours of stroke symptom onset
- National Institute of Health Stroke Scale (NIHSS) ≥ 6
Key exclusion criteria (15 listed)
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- Associated myocardial infarction or severe infection (endocarditis or sepsis)
- Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) or > 3.0 or platelets count < 40 x 10^9/L or PTT/APTT > 50 sec
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
- Baseline glucose < 2.7 or > 22.2 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penumbra SystemPenumbra System | Device | Patients with acute ischemic stroke |
Primary outcome
mTICI Score
Time frame: Immediate Post Procedure
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score of 2b or higher. mTICI scale ranges from 0 to 3 with higher values representing better outcomes.
Functional Subject Outcome
Time frame: 90 days post
Good functional subject outcome at 90 days post-procedure as defined by modified Rankin Scale (mRS) 0-2. mRS scale from from 0 to 6 with higher values representing a worse outcome.
All-cause mortality at 90 days
Time frame: 90 days
All-cause mortality at 90 days
8 secondary outcomes
Safety: Device and procedure related SAE
Time frame: Up to 30 days Post Procedure
Safety: Occurrence of ENT
Time frame: Immediate Post Procedure
Safety: Occurrence of Symptomatic intracranial hemorrhage
Time frame: Up to 24 Hours Post Procedure
Procedural Time
Time frame: Immediate Post Procedure
Stroke Onset to Revascularization
Time frame: Immediate Post Procedure
Complete Revascularization
Time frame: Immediate Post Procedure
Length of index hospital stay
Time frame: Up to 90 days Post Procedure
Type of Discharge Facility
Time frame: Up to 90 days Post Procedure
Results and safety
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Ischemic
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Penumbra Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision to focus on other studies. No safety concern). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mTICI Score (time frame: Immediate Post Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.