Trevo Aspiration Proximal Flow Control Registry

Stroke, Ischemic Clinical Trial

— TRAP  

Official title:

TRevo Aspiration Proximal Flow Control for Endovascular Stroke Intervention Data Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03199404
• Other study ID #: TRAPv1.9
• Status: Terminated
• Start date: June 6, 2017
• Est. completion date: October 3, 2019

Study information

• Verified date: October 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This purpose of this retrospective, single-arm, non-randomized, multi-center study is to collect real-world data on the effectiveness of using the TRAP technique in acute ischemic stroke patients undergoing mechanical thrombectomy.

Description:

The TRAP Registry is designed to collect real-world data on the use of the TRAP technique for mechanical thrombectomy in stroke patients. Recanalization success (as assessed using a TICI Score), along with the time to recanalization and number of passes needed for success will be assessed at the conclusion of the procedure. In addition, neurologic recovery (as evaluated using the Modified Rankin Scale and National Institutes of Health Score) will be assessed at 24 hours, discharge, and 90 days after the thrombectomy procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)

• Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel

• Subjects that range in age from 18-85

• Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30

• Subjects that the operator feels may be treated with endovascular therapy

• Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better

• Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)

• Subjects who have consented in accordance with local Institutional Review Board requirements

Exclusion Criteria:

• Absence of large vessel occlusion on neuroimaging

• Evidence of tandem occlusion on neuroimaging

• Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction

• Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)

• Previously documented contrast allergy that is not amenable to medical treatment

• Women who are pregnant or breastfeeding at time of intervention

• Evidence of brain hemorrhage on CT and/or MRI at presenting hospital

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Device:
• TRAP
Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization after Endovascular Intervention	Revascularization as assessed via Thrombolysis in Cerebral Infarction (TICI) score (TICI 2b/3) in affected vessels	Day 0: Conclusion of Thrombectomy Procedure
Primary	Time to Recanalization	The time required to attain recanalization (TICI 2b/3) in affected vessels	Day 0: Conclusion of Thrombectomy Procedure
Primary	Number of Passes for Recanalization	The total number of passes with the stent retriever need to attain recanalization will be captured.	Day 0: Conclusion of Thrombectomy Procedure
Primary	Distal Emboli	Incidence of distal emboli (both to affected vessel and new vessel) will be assessed	Day 0: Conclusion of Thrombectomy Procedure
Secondary	Neurologic Outcomes	Neurologic recovery as assessed by the National Institutes of Health Stroke Scale	90 days after treatment
Secondary	Functional Outcomes	Neurologic recovery as assessed by the Modified Rankin Scale	90 days after treatment
Secondary	Adverse Events	Incidence of serious procedure-related adverse events will be captured	Day 1, Day 5-7 and Day 90
Secondary	TRAP Technique	Success of using all components of the TRAP technique will be assessed by questionnaire for the interventionalist	Day 0: Conclusion of thrombectomy procedure