COMPASS Trial: a Direct Aspiration First Pass Technique

NCT02466893 | Completed DMC

• 1 other identifier: PRO00043325
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cost effectiveness of ADAPT approach

  2 years

Study Arms (1)

ADAPT Technique/Standard SR Group

OTHER

Other: Adapt/Standard Stent Retriever (SR) Group

Interventions

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.

ADAPT Technique/Standard SR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29461, United States

Location

Related Publications (3)

• 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.

  PMID: 30860055 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.

  PMID: 29463619 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.

  PMID: 28428348 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Acclimatization; Population Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena; Demography; Population Characteristics

Study Officials

• Aquilla Turk, DO

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

US (1)