COMPASS Trial: a Direct Aspiration First Pass Technique

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02466893
• Date of registration: 10/04/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of South Carolina
• Public title: COMPASS Trial: a Direct Aspiration First Pass Technique COMPASS
• Scientific title: COMPASS Trial: a Direct Aspiration First Pass Technique
• Date of first enrolment: June 2015
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02466893
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Aquilla Turk, DO
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Cerebrovascular Accident

Intervention(s)

Other: Adapt/Standard Stent Retriever (SR) Group

Primary Outcome(s)

90-day global disability assess via the modified Rankin Scale score (mRS) [Time Frame: 2 years]

Secondary Outcome(s)

Cost effectiveness of ADAPT approach [Time Frame: 2 years]

Secondary ID(s)

PRO00043325

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Icahn School of Medicine at Mount Sinai