Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy "MR RESCUE"

Completed

Phase 2 Results

Update History

27 Mar '14
The eligibility criteria were updated.
New
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
Old
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 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection - INR > 3.0 - PTT > 3 x Normal - 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
12 Jan '12
The eligibility criteria were updated.
New
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 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection - INR > 3.0 - PTT > 3 x Normal - 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
Old
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 0-1 - Allowed but not required: patients treated with IV tPA 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection - INR > 3.0 - PTT > 3 x Normal - 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
A location was updated in Los Angeles.
New
The overall status was removed for University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300.
A location was updated in Los Angeles.
New
The overall status was removed for Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048.
A location was updated in Los Angeles.
New
The overall status was removed for Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027.
A location was updated in San Diego.
New
The overall status was removed for University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3.
A location was updated in Washington.
New
The overall status was removed for Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW.
A location was updated in Miami.
New
The overall status was removed for University of Miami 1400 NW 10th Street, 10th Floor, Miami FL 33136.
A location was updated in Boston.
New
The overall status was removed for Boston University, One Boston Medical Center Place, Department of Neurology, C329.
A location was updated in Boston.
New
The overall status was removed for Massachusetts General Hospital, 101 Huntington Ave Ste 300.
A location was updated in St. Louis.
New
The overall status was removed for St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard Saint Louis, MO.
A location was updated in New York.
New
The overall status was removed for Columbia University, 710 W 168th St, NI 551, ,.
A location was updated in New York.
New
The overall status was removed for Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141.
A location was updated in Cincinnati.
New
The overall status was removed for University of Cincinnati, Department of Neurology, University of Cincinnati Medical Center, 231 Albert Sabin Way, Medical Sciences Bldg, Rm 4015, PO Box 670525.
A location was updated in Pittsburgh.
New
The overall status was removed for University of Pittsburgh, PUHC-426, 200 Lothrop Street.
A location was updated in Houston.
New
The overall status was removed for University of Texas at Houston, University of Texas, Houston Stroke Program, Department of Neurology, 6431 Fannin Street, MSB 7044.
A location was updated in Morgantown.
New
The overall status was removed for West Virginia University 1 Medical Center, Morgantown WV 26506.
6 Oct '11
The eligibility criteria were updated.
New
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 0-1 - Allowed but not required: patients treated with IV tPA 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection - INR > 3.0 - PTT > 3 x Normal - 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
Old
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 0-1 - Allowed but not required: patients treated with IV tPA 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection - INR > 3.0 - PTT > 3 x Normal - 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