Phase 2
N=118
Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00389467 ↗Enrolled (actual)
118
Serious AEs
62.7%
Results posted
Mar 2014
Primary outcome: Primary: The Modified Rankin Scale Score — 3.9; 3.4; 4.0; 4.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Merci Retriever and Penumbra System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Modified Rankin Scale Score |
3.9; 3.4; 4.0; 4.4 | — |
| SECONDARY Symptomatic Hemorrhagic Transformation |
3; 2; 0; 0 | — |
| SECONDARY Day 90 Mortality |
6; 7; 6; 6 | — |
Summary
The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.
Eligibility Criteria
Inclusion Criteria
- New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6)
- Age >/= 18 ≤ 85
- Clot retrieval procedure can be initiated within 8 hours from onset
- Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA)
- Pretreatment MRI performed according to MR RESCUE protocol
- Signed informed consent obtained from the patient or patient's legally authorized representative
- Premorbid modified Rankin score of 0-2
- Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion)
Exclusion Criteria
- NIHSS >/= 30
- Contraindication to MRI (pacemaker etc)
- Acute intracranial hemorrhage
- Coma
- Rapidly improving neurological signs prior to randomization
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- Pregnancy
- Known allergy to iodine previously refractory to pretreatment medications
- Current participation in another experimental treatment protocol
- Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
- INR > 3.0 (international normalized ratio)
- PTT > 3 x Normal (partial thromboplastin time)
- Imaging data cannot be processed by the MR RESCUE computer
- Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)
MRI Exclusion Criteria:
- Contraindication to MRI (pacemaker, etc)
CT Exclusion Criteria:
- Contraindication to iodinated contrast**
**Examples of possible iodinated contrast contraindications include:
- Hyperthyroidism
- History of severe allergic reaction to iodinated contrast material
- History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- Paraproteinemia syndromes or multiple myeloma
- Collagen vascular disease
- Severe cardiac insufficiency
- Severely compromised liver function
- Current therapy with metformin, aminoglycosides
Data sourced from ClinicalTrials.gov (NCT00389467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.