NCT03474549: TIGER

Treatment With Intent to Generate Endovascular Reperfusion

Completed NA Results posted Last updated 8 May 2024

What this trial tests

NA trial testing Tigertriever revascularization device in Ischemic Stroke in 160 participants. Completed in 30 June 2020.

Timeline

9 May 2018

Primary endpoint
15 April 2020

30 June 2020

Quick facts

Lead sponsor	Rapid Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	9 May 2018
Primary completion	15 April 2020
Estimated completion	30 June 2020
Sites	17 locations across United States, Israel

Drugs / interventions tested

• Tigertriever revascularization device

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Rapid Medical

Who can join

Adults 18 to 85, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Successful Reperfusion, Defined as mTICI Score ≥ 2b Primary · Day 0 (end of procedure)

Effectiveness (Successful reperfusion)

Group	Value	95% CI
Tigertriever Revascularization Device	130

All-cause Mortality Primary · 90 days post treatment

Safety (All-cause mortality)

Group	Value	95% CI
Tigertriever Revascularization Device	31

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 Primary · 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.

Group	Value	95% CI
Tigertriever Revascularization Device	3

Modified Rankin Scale (mRS) Score of ≤2 Secondary · 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.

Group	Value	95% CI
Tigertriever Revascularization Device	86

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tigertriever Revascularization Device

Serious: 71/160 (44%)

Deaths: 31/160

Serious adverse events (12 terms)

Reaction	System	Tigertriever Revasculariza…
Nervous system disorders	Nervous system disorders	—
Cardiac disorders	Cardiac disorders	—
Vascular disorders	Vascular disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Infections and infestations	Infections and infestations	—
Gastrointestinal disorders	Gastrointestinal disorders	—
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—
General disorders and administration site conditions	General disorders	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—
Musculoskeletal and connective tissue disorders|Psychiatric disorders	Musculoskeletal and connective tissue disorders	—
Surgical and medical procedures	Surgical and medical procedures	—

Other adverse events (16 terms — click to expand)

Reaction	System	Tigertriever Revasculariza…
Cardiac disorders	Cardiac disorders	—
Gastrointestinal disorders	Gastrointestinal disorders	—
Nervous system disorders	Nervous system disorders	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—
Vascular disorders	Vascular disorders	—
Infections and infestations	Infections and infestations	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—
General disorders and administration site conditions	General disorders	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	—
Renal and urinary disorders	Renal and urinary disorders	—
Investigations	Investigations	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Ear and labyrinth disorders	Ear and labyrinth disorders	—
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—
Surgical and medical procedures	Surgical and medical procedures	—

Most-reported serious reactions: Nervous system disorders, Cardiac disorders, Vascular disorders, Injury, poisoning and procedural complications, Infections and infestations, Gastrointestinal disorders, Respiratory, thoracic and mediastinal disorders, Blood and lymphatic system disorders.

Data from ClinicalTrials.gov NCT03474549 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial.
   Gupta R, Saver JL, Levy E, Zaidat OO, et al · · 2021 · cited 38× · PMID 33739136 · DOI 10.1161/strokeaha.121.034436