Treatment With Intent to Generate Endovascular Reperfusion (TIGER)
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|ClinicalTrials.gov Identifier: NCT03474549|
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : July 21, 2020
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.
The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Device: Tigertriever revascularization device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment With Intent to Generate Endovascular Reperfusion|
|Actual Study Start Date :||May 9, 2018|
|Actual Primary Completion Date :||April 15, 2020|
|Actual Study Completion Date :||June 30, 2020|
Experimental: Tigertriever revascularization device
Mechanical thrombectomy with Tigertriever
Device: Tigertriever revascularization device
- Successful reperfusion, defined as mTICI Score ≥ 2b [ Time Frame: Day 0 (end of procedure) ]Effectiveness (Successful reperfusion)
- All-cause mortality [ Time Frame: 90 days post treatment ]Safety (All-cause mortality)
- Symptomatic intracranial hemorrhage (sICH) defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 hours [ Time Frame: 24 hours post procedure ]Safety (Symptomatic intracranial hemorrhage (sICH)) defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 hours.
- modified Rankin Scale (mRS) score of ≤2 [ Time Frame: 90 days post treatment ]modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474549
|Principal Investigator:||Jeffrey L Saver, Dr.||Geffen School of Medicine at UCLA|
|Principal Investigator:||Rishi Gupta, Dr.||WellStar Medical Group|