COMPASS Trial: a Direct Aspiration First Pass Technique

Completed · Not applicable

Conditions studied: Ischemic Cerebrovascular Accident

In brief

Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials utilizing advanced imaging to identify patients with large vessel occlusions amenable to intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT approach has shown superior technical results with similar functional outcomes while lowering procedure time and device costs versus traditional stent retriever as a first line therapy approaches

Key facts

Study ID

NCT02466893

Run by

Medical University of South Carolina

People needed

250

Starts

2015-06-01

Expected to finish

2018-02-01

Last updated by the study team

2018-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 and older (i.e., candidates must have had their 18th birthday)
• NIHSS ≥8 at the time of neuroimaging
• Presenting or persistent symptoms within 6 hours of when groin puncture can be obtained
• Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation)
• The operator feels that the stroke can be appropriately treated with traditional endovascular approaches (the ADAPT approach or conventional first-line stent retriever approach)
• Pre-event Modified Rankin Scale score 0-1
• Non-contrast CT/CTA for trial eligibility performed or repeated at treating ADAPT stroke center.
• Consenting requirements met according to local IRB

You may not qualify if…

• Patient is more than 6-hours from symptom onset
• Rapidly improving neurologic examination
• Absence of large vessel occlusion on non-invasive imaging
• Presence of an existing or pre-existing large territory infarction
• Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
• Absent femoral pulses
• Excessive vascular access tortuosity that will likely result in unstable access platform.
• Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
• Severe contrast allergy or absolute contraindication to iodinated contrast.
• Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
• Patient has a severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
• Head CT or MRI Scan Exclusion Criteria
• Presence of blood on imaging (subarachnoid hemorrhage (SAH)), intracerebral hemorrhage (ICH), etc.)
• High density lesion consistent with hemorrhage of any degree
• Significant mass effect with midline shift
• Core infarct lesion volume >50 cc.
• Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan or ASPECTS of < 7; Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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