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COMPASS Trial: a Direct Aspiration First Pass Technique (COMPASS)

Primary Purpose

Ischemic Cerebrovascular Accident

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adapt/Standard Stent Retriever (SR) Group

About this trial

This is an interventional treatment trial for Ischemic Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ADAPT Technique/Standard SR Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02466893

First Posted

April 10, 2015

Last Updated

February 9, 2018

Sponsor

Medical University of South Carolina

Collaborators

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02466893

Brief Title

COMPASS Trial: a Direct Aspiration First Pass Technique

Acronym

COMPASS

Official Title

COMPASS Trial: a Direct Aspiration First Pass Technique

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

Collaborators

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Cerebrovascular Accident

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ADAPT Technique/Standard SR Group

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Adapt/Standard Stent Retriever (SR) Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

90-day global disability assess via the modified Rankin Scale score (mRS)

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Cost effectiveness of ADAPT approach

Description

Demonstrate that the ADAPT approach is technically a superior and more cost effective approach than primary stent retriever use in the treatment of AIS.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aquilla Turk, DO

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29461

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30860055

Citation

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.

Results Reference

derived

PubMed Identifier

29463619

Citation

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.

Results Reference

derived

PubMed Identifier

28428348

Citation

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. Erratum In: Stroke. 2017 Jun;48(6):e152.

Results Reference

derived

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COMPASS Trial: a Direct Aspiration First Pass Technique

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