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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT Technique/Standard SR Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapt/Standard Stent Retriever (SR) Group | Other | If the patient is randomized to mechanical thrombectomy, the groin puncture to initiate the procedure should occur within 1 hour of the clinical imaging used to determine trial candidacy. An introducer sheath will be placed in the femoral artery. Diagnostic angiography is initially performed via the transfemoral approach with catheterization of the carotid artery appropriate to the patient's presenting symptoms. Once thrombus in the appropriate vessel is identified, the thrombectomy procedure will be initiated. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day global disability assess via the modified Rankin Scale score (mRS) | The primary objective is to show that AIS patients, with appropriate image selection, treated with ADAPT mechanical thrombectomy approach within 6 hours of symptom onset do not have inferior clinical outcomes to those treated with a first-line stent retriever approach with 90-day global disability assessed via the modified Rankin Scale score (mRS), analyzed using success criteria as mRS 0 to 2. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness of ADAPT approach | Demonstrate that the ADAPT approach is technically a superior and more cost effective approach than primary stent retriever use in the treatment of AIS. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Head CT or MRI Scan Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Aquilla Turk, DO | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30860055 | Derived | Turk AS 3rd, Siddiqui A, Fifi JT, De Leacy RA, Fiorella DJ, Gu E, Levy EI, Snyder KV, Hanel RA, Aghaebrahim A, Woodward BK, Hixson HR, Chaudry MI, Spiotta AM, Rai AT, Frei D, Almandoz JED, Kelly M, Arthur A, Baxter B, English J, Linfante I, Fargen KM, Mocco J. Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial. Lancet. 2019 Mar 9;393(10175):998-1008. doi: 10.1016/S0140-6736(19)30297-1. | |
| 29463619 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2017 | Dec 6, 2017 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000064 | Acclimatization |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D000222 | Adaptation, Physiological |
| D010829 | Physiological Phenomena |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
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|
| Derived |
| Turk AS, Siddiqui AH, Mocco J. A comparison of direct aspiration versus stent retriever as a first approach ('COMPASS'): protocol. J Neurointerv Surg. 2018 Oct;10(10):953-957. doi: 10.1136/neurintsurg-2017-013722. Epub 2018 Feb 20. |
| 28428348 | Derived | Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |