Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA)
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ClinicalTrials.gov Identifier: NCT01492725 |
Recruitment Status :
Terminated
(On DSMB advice, trial recruitment has been halted for efficacy. F/U continues)
First Posted : December 15, 2011
Last Update Posted : April 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemic Stroke | Device: Intra-arterial Clot Retrieval with Solitaire device Genetic: intravenous tissue plasminogen activator (tPA) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection. |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Intra-arterial Clot Retrieval after iv tPA |
Device: Intra-arterial Clot Retrieval with Solitaire device
Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours. |
Active Comparator: Standard care iv tPA |
Genetic: intravenous tissue plasminogen activator (tPA)
Standard care IV tPA therapy administered as per registered product information |
- Reperfusion at 24 hours (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ]
- Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) [ Time Frame: 3 days post stroke onset ]NIHSS - reduction >/= 8 points or reaching 0-1)
- Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ]
- Recanalisation at 24 hrs post stroke (CT or MR angiography) [ Time Frame: 24 hours post stroke onset ]
- Infarct growth within 24 hrs (CT and MRI) [ Time Frame: 24 hours post stroke onset ]
- Stroke severity (NIHSS) at 24 hours [ Time Frame: 24 hours post stroke onset ]
- Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment). [ Time Frame: within 36 hours of intervention ]
- Death due to any cause [ Time Frame: 3 months ]
- Modified Rankin Scale (mRS) 0-1 at 3 months [ Time Frame: 3 months ]
- Categorical shift in mRS at 3 months [ Time Frame: 3 months ]
- NIHSS reduction 8 points or reaching 0-1 at 3 months [ Time Frame: 3 months ]
- Modified Rankin Scale (mRS) 0-2 at 3 months [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients presenting with anterior circulation acute ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset
- Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
- Patient"s age is ≥18 years
-
Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
Imaging inclusion criteria
Dual target:
- Arterial occlusion on CTA or MRA of the ICA, M1 or M2
- Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume. a) Mismatch ratio of greater than 1.2, and b) Absolute mismatch volume of greater than 10 ml, and. c) Infarct core lesion volume of less than 70mL
Exclusion Criteria:
- Intracranial haemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms at the discretion of the investigator
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Inability to access the cerebral vasculature in the opinion of the neurointerventional team
- Contra indication to imaging with MR with contrast agents
- Participation in any investigational study in the previous 30 days
- Any terminal illness such that patient would not be expected to survive more than 1 year
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- Pregnant women
- Previous stroke within last three months
- Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
- Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6)
- Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
- Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Prior use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) is permitted.
- Clinically significant hypoglycaemia.
- Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator.
- Hereditary or acquired haemorrhagic diathesis
- Gastrointestinal or urinary bleeding within the preceding 21 days
- Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
- Exposure to a thrombolytic agent within the previous 72 hrs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492725
Australia, New South Wales | |
John Hunter Hospital | |
New Lambton Heights, New South Wales, Australia, 2305 | |
Royal North Shore Hospital | |
St Leonards, New South Wales, Australia, 2605 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
Western Hospital | |
Melbourne, Victoria, Australia, 3011 | |
Austin Hospital | |
Melbourne, Victoria, Australia, 3084 | |
Box Hill Hospital | |
Melbourne, Victoria, Australia, 3128 | |
Monash Medical Centre | |
Melbourne, Victoria, Australia, 3168 | |
Royal Melbourne Hospital | |
Melbourne, Victoria, Australia | |
New Zealand | |
Auckland Hospital | |
Grafton, Auckland, New Zealand, 1001 |
Responsible Party: | Neuroscience Trials Australia |
ClinicalTrials.gov Identifier: | NCT01492725 |
Other Study ID Numbers: |
NTA1101 |
First Posted: | December 15, 2011 Key Record Dates |
Last Update Posted: | April 21, 2015 |
Last Verified: | December 2014 |
Ischemic Stroke Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Plasminogen Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |