COMPASS Trial: a Direct Aspiration First Pass Technique "COMPASS"

Active, not recruiting

Phase N/A Results N/A

Update History

4 Oct '17
The Summary of Purpose was updated.
New
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
Old
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
The description was updated.
New
This is a prospective, randomized trial comparing mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with AIS within 6 hours of symptom onset. Any cleared mechanical stent retriever (SR) or aspiration catheter device that is in common use in the operator's region of practice is approved for use. Prior to releasing any sites to enroll patients, we will collect the following information on the most recent 20 acute ischemic stroke cases, at least five of which must have used direct aspiration as a first approach, and at least five of which must have used stent retrievers as a first approach. It is permissible to go back in time farther than the most recent 20 cases to fulfill either or both of these requirements. There is no requirement for the remaining 10 cases. The datapoints to be collected include: - Age - Gender - LVO location - Side of LVO - NIHSS at presentation - Time of onset - Time of hospital arrival - Time imaging completed - Time of groin puncture - Time of revascularization, if applicable - Time procedure terminated, if revascularization was not obtained - tPA given pre-procedure - Time of IV-tPA - Imaging type - Perfusion imaging - Devices used - Passes attempted - Device success - Standard and modified final TICI scores - Outcome measurements: incidence of post-op ICH, discharge and 90 day NIHSS, discharge and 90 day mRS, any and all complications Patients who meet the inclusion and exclusion criteria, consent to participate, and who are randomized will be considered enrolled. Treatment arm will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either ADAPT or SR thrombectomy. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
Old
This is a prospective, randomized trial comparing mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with AIS within 6 hours of symptom onset. Any cleared mechanical stent retriever (SR) or aspiration catheter device that is in common use in the operator's region of practice is approved for use. Prior to releasing any sites to enroll patients, we will collect the following information on the most recent 20 acute ischemic stroke cases, at least five of which must have used direct aspiration as a first approach, and at least five of which must have used stent retrievers as a first approach. It is permissible to go back in time farther than the most recent 20 cases to fulfill either or both of these requirements. There is no requirement for the remaining 10 cases. The datapoints to be collected include: - Age - Gender - LVO location - Side of LVO - NIHSS at presentation - Time of onset - Time of hospital arrival - Time imaging completed - Time of groin puncture - Time of revascularization, if applicable - Time procedure terminated, if revascularization was not obtained - tPA given pre-procedure - Time of IV-tPA - Imaging type - Perfusion imaging - Devices used - Passes attempted - Device success - Standard and modified final TICI scores - Outcome measurements: incidence of post-op ICH, discharge and 90 day NIHSS, discharge and 90 day mRS, any and all complications Patients who meet the inclusion and exclusion criteria, consent to participate, and who are randomized will be considered enrolled. Treatment arm will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either ADAPT or SR thrombectomy. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18 and older (i.e., candidates must have had their 18th birthday) 2. NIHSS ≥8 at the time of neuroimaging 3. Presenting or persistent symptoms within 6 hours of when groin puncture can be obtained 4. Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation) 5. The operator feels that the stroke can be appropriately treated with traditional endovascular approaches (the ADAPT approach or conventional first-line stent retriever approach) 6. Pre-event Modified Rankin Scale score 0-1 7. Non-contrast CT/CTA for trial eligibility performed or repeated at treating ADAPT stroke center. 8. Consenting requirements met according to local IRB Exclusion Criteria: 1. Patient is more than 6-hours from symptom onset 2. Rapidly improving neurologic examination 3. Absence of large vessel occlusion on non-invasive imaging 4. Presence of an existing or pre-existing large territory infarction 5. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 6. Absent femoral pulses 7. Excessive vascular access tortuosity that will likely result in unstable access platform. 8. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive. 9. Severe contrast allergy or absolute contraindication to iodinated contrast. 10. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. 11. 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.
Old
Inclusion Criteria: 1. Age 18 and older (i.e., candidates must have had their 18th birthday) 2. NIHSS ≥8 at the time of neuroimaging 3. Presenting or persistent symptoms within 6 hours of when groin puncture can be obtained 4. Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation) 5. The operator feels that the stroke can be appropriately treated with traditional endovascular approaches (the ADAPT approach or conventional first-line stent retriever approach) 6. Pre-event Modified Rankin Scale score 0-1 7. Non-contrast CT/CTA for trial eligibility performed or repeated at treating ADAPT stroke center. 8. Consenting requirements met according to local IRB Exclusion Criteria: 1. Patient is more than 6-hours from symptom onset 2. Rapidly improving neurologic examination 3. Absence of large vessel occlusion on non-invasive imaging 4. Presence of an existing or pre-existing large territory infarction 5. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 6. Absent femoral pulses 7. Excessive vascular access tortuosity that will likely result in unstable access platform. 8. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive. 9. Severe contrast allergy or absolute contraindication to iodinated contrast. 10. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. 11. 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.
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.
22 Dec '15
Trial acronym was updated.
New
COMPASS
Trial name was updated.
New
COMPASS Trial: a Direct Aspiration First Pass Technique
3 Oct '15
The Summary of Purpose was updated.
New
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
Old
Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe and effective for treatment of Acute ischemic Stroke (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 of stent retrievers over medical therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT technique has shown superior technical results with similar functional outcomes while lowering procedure time and device costs.
The description was updated.
New
This is a prospective, randomized trial comparing mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with AIS within 6 hours of symptom onset. Any cleared mechanical stent retriever (SR) or aspiration catheter device that is in common use in the operator's region of practice is approved for use. Prior to releasing any sites to enroll patients, we will collect the following information on the most recent 20 acute ischemic stroke cases, at least five of which must have used direct aspiration as a first approach, and at least five of which must have used stent retrievers as a first approach. It is permissible to go back in time farther than the most recent 20 cases to fulfill either or both of these requirements. There is no requirement for the remaining 10 cases. The datapoints to be collected include: - Age - Gender - LVO location - Side of LVO - NIHSS at presentation - Time of onset - Time of hospital arrival - Time imaging completed - Time of groin puncture - Time of revascularization, if applicable - Time procedure terminated, if revascularization was not obtained - tPA given pre-procedure - Time of IV-tPA - Imaging type - Perfusion imaging - Devices used - Passes attempted - Device success - Standard and modified final TICI scores - Outcome measurements: incidence of post-op ICH, discharge and 90 day NIHSS, discharge and 90 day mRS, any and all complications Patients who meet the inclusion and exclusion criteria, consent to participate, and who are randomized will be considered enrolled. Treatment arm will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either ADAPT or SR thrombectomy. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
Old
The most devastating strokes are generally those caused by proximal occlusions in the cervical and cerebral vasculature. The natural history of untreated or un-revascularized large vessel occlusions in acute stroke patients results in mortality rates approaching 30% and only 25% of patients achieving good neurologic outcomes at 90 days. Intravenous (IV) tissue plasminogen activator (tPA) administration is approved for use within 3 hours of symptom onset, with newer evidence suggesting potential benefit out to 4.5 hours. However, IV tPA does a poor job of effectively revascularizing large vessel occlusions. Among patients presenting within the approved time window, close to half are ineligible to receive IV tPA due to exclusionary criteria. Until recently, there has not been a single trial showing efficacy of intra-arterial thrombectomy (IAT) over medical therapy. The MR CLEAN trial showed an absolute difference of 13.5% in rate of functional independence in favor of IAT over medical therapy (32.6% vs 19.1%). MR CLEAN was notable in that it randomized 500 patients in the Netherlands to IV-tPA vs IV tPA and IAT presenting within 6 hours of stroke onset. More robustly, the ESCAPE trial favored IAT over medical therapy by an odds ratio of 2.6 with a significant reduction in mortality (10.4% vs 19.0%). The ESCAPE trial was halted after enrolling 316 patients at 22 centers around the world presenting within 12 hours of stroke onset. ESCAPE was notable in that the trial focused on a select group of high volume centers around the world to do a large number of cases with focus on high technical quality. The trial required advanced imaging to select patients with Large Vessel Occlusion (LVO) and ability to rapidly transition from diagnosis to IAT within 30 minutes. Similarly, the EXTEND IA trial based in Australia, was halted after 70 patients were enrolled due to the reported positive results in the MR CLEAN trial. Interim analysis found a marked improvement in ability to achieve functional outcome with IAT (71%) over medical therapy (40%). These trials all utilized advanced imaging to select appropriate patients and stent retrievers were used for thrombectomy in the majority of cases. This new overwhelming data has created new official guidelines issued from the various stroke societies with stent retrievers recommended with Grade A, Level 1a evidence and aspiration devices used upon the neurointerventionists discretion if rapid, complete and safe revascularisation of the target vessel can be achieved with Grade C, Level 2a evidence (ESNR, European Society of Minimally Invasive Neurological Therapy ((ESMINT) and Karolinska). ADAPT is a technique that utilizes the advantages of large bore aspiration catheters that can be easily tracked into the cerebral circulation to directly remove thrombus with a vacuum phenomenon. If this application is not directly effective, then it maintains the thrombus engaged in the catheter tip through suction and the clot is removed as the catheter is pulled out of the body. In the minority of cases where the application of aspiration is not successful in removing the blockage, then the large aspiration catheter provides a conduit for use of a stent retriever at the location of the thrombus. Initial experience with this technique has shown promising results; however, randomized or direct comparison studies have not been done. ADAPT, while encompassing the advantages of aspiration with the rescue opportunity of stent retrievers in select cases has not been rigorously tested directly against the technique of stent retrievers as the sole therapy. While inherently suggestive, supportive data on the benefit of aspiration as a front line therapy is sparse. The purpose of this study is to demonstrate that patients treated prospectively with the ADAPT technique do not have inferior clinical functional outcomes as those with a stent retriever primarily.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Age 18 and older (i.e., candidates must have had their 18th birthday) 2. NIHSS ≥8 at the time of neuroimaging 3. Presenting or persistent symptoms within 6 hours of when groin puncture can be obtained 4. Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation) 5. The operator feels that the stroke can be appropriately treated with traditional endovascular approaches (the ADAPT approach or conventional first-line stent retriever approach) 6. Pre-event Modified Rankin Scale score 0-1 7. Non-contrast CT/CTA for trial eligibility performed or repeated at treating ADAPT stroke center. 8. Consenting requirements met according to local IRB Exclusion Criteria: 1. Patient is more than 6-hours from symptom onset 2. Rapidly improving neurologic examination 3. Absence of large vessel occlusion on non-invasive imaging 4. Presence of an existing or pre-existing large territory infarction 5. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 6. Absent femoral pulses 7. Excessive vascular access tortuosity that will likely result in unstable access platform. 8. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive. 9. Severe contrast allergy or absolute contraindication to iodinated contrast. 10. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. 11. 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.
Old
Inclusion Criteria: 1. Age 18 and older (i.e., candidates must have had their 18th birthday) 2. National Institutes of Health Stroke Scale (NIHSS) ≥8 at the time of neuroimaging 3. Presenting or persistent symptoms within 6 hours of when groin puncture can be obtained 4. Neuroimaging demonstrates large vessel proximal occlusion (distal Internal Carotid Artery (ICA) through Middle Cerebral Artery (MCA M1) bifurcation) 5. The operator feels that the stroke can be appropriately treated with traditional endovascular techniques (endovascular mechanical thrombectomy without adjunctive devices such as a permanently implanted stent) 6. Pre-event Modified Rankin Scale score 0-1 7. Non-contrast CT/Computed Tomography Angiogiography (CTA) for trial eligibility performed or repeated at treating ADAPT stroke center. 8. Consenting requirements met according to local Institutional Review Board (IRB) Exclusion Criteria: 1. Patient is more than 6-hours from symptom onset 2. Rapidly improving neurologic examination 3. Absence of large vessel occlusion on non-invasive imaging 4. Presence of a existing or pre-existing large territory infarction 5. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 6. Absent femoral pulses 7. Excessive vascular access tortuousity that will likely result in unstable access platform. 8. Pregnancy; if a woman is of child--‐bearing potential a urine or serum beta Human Chorionic Gonadotropin (HCG) test is positive. 9. Severe contrast allergy or absolute contraindication to iodinated contrast. 10. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. 11. 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. - Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment. - 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.
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.