Imaging Guided Patient Selection for Interventional Revascularization Therapy (START)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT00963989
First received: August 18, 2009
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Device: Penumbra System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The START Trial: Clinical Outcome in Acute Stroke Treatment After Imaging Guided Patient Selection for Interventional Revascularization Therapy

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Functional outcome as defined by a mRS of 0-2 at 90 days post-procedure [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: No ]
  • Angiographic assessment of vessel patency as measured by TIMI and modified TICI scores at immediate post-procedure [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: No ]
  • Procedural serious adverse events during the procedure [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Good neurological recovery post-procedure as defined by a 10 points or more improvement on the NIHSS at Discharge [ Time Frame: At Discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All cause mortality at 90 days post-procedure [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Penumbra Device Arm Device: Penumbra System
The Penumbra System is used to revascularize clotted cerebral blood vessels.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963989

Locations
United States, South Carolina
Medical University of South Carolina
Charleston,, South Carolina, United States, 29425
Sponsors and Collaborators
Penumbra Inc.
Investigators
Study Director: Siu P Sit, PhD Penumbra Inc.
  More Information

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT00963989     History of Changes
Other Study ID Numbers: CLP 2480.A
Study First Received: August 18, 2009
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penumbra Inc.:
Acute stroke
Large cerebral vessel occlusion
Core infarct volume
Penumbra System
Revascularization
Intracerebral hemorrhage
mRS
NIHSS
Procedural serious adverse events
All cause mortality

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014