Acute Ischemic StrokeSTARTNCT00963989
Imaging Guided Patient Selection for Interventional Revascularization Therapy
A study testing Penumbra System in people with Acute Ischemic Stroke, run by Penumbra Inc. at 1 site in United States.
Trial summary
The primary objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Penumbra System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- From 18 to 85 years of age.
- Evidence of proximal anterior circulation large vessel occlusion (TIMI /TICI 0-1) (Tables 2A \& B). Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA.
- Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
- At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score of 10 or greater.
- Core infarct volume assessed by CTP, CTA or DWI scans within 60 minutes to arterial puncture.
- Signed informed consent.
Who cannot join
- History of stroke in the past 3 months.
- Vessel tortuosity too difficult to allow endovascular access.
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score of 1 or greater.
- Known severe allergy to contrast media.
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
- Noncontrast CT evidence of the following conditions before enrollment:
Show all 12Show fewer
- Significant mass effect with midline shift;
- Evidence of intracranial hemorrhage.
- Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal.
- Angiographic evidence of preexisting arterial injury.
- Life expectancy less than 90 days.
- Participation in another clinical investigation that could confound the evaluation of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The START Trial: Clinical Outcome in Acute Stroke Treatment After Imaging Guided Patient Selection for Interventional Revascularization Therapy
The primary objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission. The secondary objective is to determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure.
Read the detailed description
Study Title: The START Trial: Clinical Outcome in Acute Stroke Treatment after Imaging Guided Patient Selection for Interventional Revascularization Therapy
Study Objective: The objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom onset and with a known core infarct volume at admission. The data will also be used to determine if there is a correlation between infarct volume and functional outcome at 90 days post-procedure. Safety is defined by the procedural serious adverse events, and effectiveness is defined by the rate of revascularization (TIMI 2-3/TICI 2a-3) and good functional outcome. Good functional outcome is defined by a modified Rankin scale (mRS) score of 2 or less at 90 days post-procedure. Core infarct volume at admission will be assessed by computed tomography perfusion (CTP), computed tomography angiography (CTA) or magnetic resonance DWI scans. The core infarct volumes will be sub-grouped by <50cc, 50-100cc and >100cc to determine the correlation with patient functional outcome.
Study Design: A prospective, single arm, multi-center trial. Up to 200 patients at up to 45 centers will be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed for analysis.
Patient Population: Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with a known imaging-defined infarct volume will be enrolled for interventional treatment by the Penumbra System to achieve revascularization of the target vessel territory.
Indication: The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Sample Size Justification: Up to 200 subjects will be enrolled in order to obtain up to 150 evaluable patients. Assuming a post-procedure angiographic success (TIMI 2-3/TICI 2a-3) rate of 80% (120/150), the expected two-sided exact binomial 95% confidence interval is (72.7%, 86.1%). Assuming a 90-day mRS success (mRS 0-2) rate of 30%, the expected two-sided exact binomial 95% confidence interval is (22.8%, 38.0%). Additionally, the study results will be used for sample size estimates for a potential future randomized, concurrent controlled trial.
Core Laboratory and Clinical Event Committee An independent Core Lab will review and score all imaging scans for infarct volume, TIMI, TICI and ICH. A Clinical Event Committee will adjudicate all Serious Adverse Events for severity and causality (disease-, procedure-, drug-, or device-relatedness.
Study Rationale: Use of interventional revascularization techniques offer several potential clinical benefits by improving cerebral perfusion to the target vascular territory in certain patients. The validation of a simple, pragmatic, and executable image guided patient selection paradigm may identify a cohort of acute stroke patients who will benefit from interventional treatment by the Penumbra System and in whom revascularization as a treatment for acute stroke will be indicated.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Penumbra System
- Keywords
- Acute stroke, Large cerebral vessel occlusion, Core infarct volume, Penumbra System, Revascularization, Intracerebral hemorrhage, mRS, NIHSS, Procedural serious adverse events, All cause mortality
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra SystemDevice
The Penumbra System is used to revascularize clotted cerebral blood vessels.
| Study group | Role | What they receive |
|---|---|---|
| Penumbra Device Arm | Experimental | Not described Receives: Device: Penumbra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure
Modified Rankin Scale (mRS) ranges from 0 to 5, with higher scores being worse.
Measured: At 90 days post-procedure
Angiographic Assessment of Vessel Patency as Measured by TIMI Score
Defined by Number of participants with Thrombolysis in Myocardial Infarction (TIMI) 2-3.
A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.
Measured: At immediate post-procedure
Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score
Defined by number of participants with modified thrombolysis in cerebral infarction (TICI) 2-3.
A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.
Measured: At immediate post-procedure
Procedural Serious Adverse Events During the Procedure
Defined by serious adverse events (SAEs) within 24 hours of the procedure
Measured: During the procedure, approximately 24 hours
Secondary outcomes (3)
Good Neurological Recovery Post-procedure as Defined by a 10 Points or More Improvement on the NIHSS at Discharge
Measured: At Discharge, an average of 7 days
Incidence of Symptomatic and Asymptomatic Hemorrhage Based on the ECASS Criteria and Patient Neurological Status Within 24 Hours of the Procedure
Measured: Within 24 hours of the procedure
All Cause Mortality at 90 Days Post-procedure
Measured: At 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 posted24 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siu P Sit, PhD, Study director, Penumbra Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963989
- Sponsor's protocol ID
- CLP 2480.A
- Acronym
- START
- Status last verified
- Nov 2021
- First submitted
- 18 Aug 2009
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The START Trial: Clinical Outcome in Acute Stroke Treatment After Imaging Guided Patient Selection for Interventional Revascularization Therapy
- ClinicalTrials.gov ID
- NCT00963989
- Acronym / sponsor ID
- START / CLP 2480.A
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute stroke, Large cerebral vessel occlusion, Core infarct volume, Penumbra System, Revascularization, Intracerebral hemorrhage, mRS, NIHSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Posted 23 Nov 2021
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 clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission. The secondary objective is to determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure.
Detailed description
Study Title: The START Trial: Clinical Outcome in Acute Stroke Treatment after Imaging Guided Patient Selection for Interventional Revascularization Therapy
Study Objective: The objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom onset and with a known core infarct volume at admission. The data will also be used to determine if there is a correlation between infarct volume and functional outcome at 90 days post-procedure. Safety is defined by the procedural serious adverse events, and effectiveness is defined by the rate of revascularization (TIMI 2-3/TICI 2a-3) and good functional outcome. Good functional outcome is defined by a modified Rankin scale (mRS) score of 2 or less at 90 days post-procedure. Core infarct volume at admission will be assessed by computed tomography perfusion (CTP), computed tomography angiography (CTA) or magnetic resonance DWI scans. The core infarct volumes will be sub-grouped by <50cc, 50-100cc and >100cc to determine the correlation with patient functional outcome.
Study Design: A prospective, single arm, multi-center trial. Up to 200 patients at up to 45 centers will be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed for analysis.
Patient Population: Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with a known imaging-defined infarct volume will be enrolled for interventional treatment by the Penumbra System to achieve revascularization of the target vessel territory.
Indication: The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Sample Size Justification: Up to 200 subjects will be enrolled in order to obtain up to 150 evaluable patients. Assuming a post-procedure angiographic success (TIMI 2-3/TICI 2a-3) rate of 80% (120/150), the expected two-sided exact binomial 95% confidence interval is (72.7%, 86.1%). Assuming a 90-day mRS success (mRS 0-2) rate of 30%, the expected two-sided exact binomial 95% confidence interval is (22.8%, 38.0%). Additionally, the study results will be used for sample size estimates for a potential future randomized, concurrent controlled trial.
Core Laboratory and Clinical Event Committee An independent Core Lab will review and score all imaging scans for infarct volume, TIMI, TICI and ICH. A Clinical Event Committee will adjudicate all Serious Adverse Events for severity and causality (disease-, procedure-, drug-, or device-relatedness.
Study Rationale: Use of interventional revascularization techniques offer several potential clinical benefits by improving cerebral perfusion to the target vascular territory in certain patients. The validation of a simple, pragmatic, and executable image guided patient selection paradigm may identify a cohort of acute stroke patients who will benefit from interventional treatment by the Penumbra System and in whom revascularization as a treatment for acute stroke will be indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penumbra Device Arm | Experimental | Device: Penumbra System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- From 18 to 85 years of age.
- Evidence of proximal anterior circulation large vessel occlusion (TIMI /TICI 0-1) (Tables 2A \& B). Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA.
- Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
- At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score of 10 or greater.
- Core infarct volume assessed by CTP, CTA or DWI scans within 60 minutes to arterial puncture.
Key exclusion criteria (12 listed)
- History of stroke in the past 3 months.
- Vessel tortuosity too difficult to allow endovascular access.
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score of 1 or greater.
- Known severe allergy to contrast media.
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
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 SystemThe Penumbra System is used to revascularize clotted cerebral blood vessels. | Device | Penumbra Device Arm |
Primary outcome
Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure
Time frame: At 90 days post-procedure
Modified Rankin Scale (mRS) ranges from 0 to 5, with higher scores being worse.
Angiographic Assessment of Vessel Patency as Measured by TIMI Score
Time frame: At immediate post-procedure
Defined by Number of participants with Thrombolysis in Myocardial Infarction (TIMI) 2-3. A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.
Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score
Time frame: At immediate post-procedure
Defined by number of participants with modified thrombolysis in cerebral infarction (TICI) 2-3. A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.
Procedural Serious Adverse Events During the Procedure
Time frame: During the procedure, approximately 24 hours
Defined by serious adverse events (SAEs) within 24 hours of the procedure
3 secondary outcomes
Good Neurological Recovery Post-procedure as Defined by a 10 Points or More Improvement on the NIHSS at Discharge
Time frame: At Discharge, an average of 7 days
Incidence of Symptomatic and Asymptomatic Hemorrhage Based on the ECASS Criteria and Patient Neurological Status Within 24 Hours of the Procedure
Time frame: Within 24 hours of the procedure
All Cause Mortality at 90 Days Post-procedure
Time frame: At 90 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Siu P Sit, PhD study director
Penumbra Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penumbra System in people with Acute Ischemic Stroke, run by Penumbra Inc. at 1 site 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure (time frame: At 90 days post-procedure). The study lists 4 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 23 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.