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TerminatedNCT03871309Updated Apr 12, 2024

Tigertriever Distal Vessels Registry

An observational study in Ischemic Stroke, sponsored by Rapid Medical. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Rapid Medical · Observational

Why this study was terminated
PI and sponsor decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
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Study summary

A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.

Read the detailed 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.

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Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's enrollment of 9 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Rapid Medical is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.

Inclusion criteria

  • Patients who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
  • Patients ≥18
  • NIHSS Score of ≥2
  • Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
  • Anticipated life expectancy of at least 6 months from presentation
  • Signed informed consent form by the patient or a legally acceptable representative.

Exclusion criteria

Exclusion Criteria:

  • Extended infarct - ischemic changes >1/3 MCA territory / 100 ml tissue or ASPECT score \<5

    • Pre- stroke mRS ≥ 2
    • Unknown time of stroke symptom onset
    • Vessel diameter \< 1mm
    • Angiographically evident extreme vessel tortuosity that may preclude the device from reaching the target area.
    • Occlusion/stenosis proximal to thrombus that precludes safe retrieval
    • Medical co-morbidities including but not limited to:
    • Uncontrolled coagulopathy such as International Normalized Ratio (INR) of > 3.0 or platelets count \< 40 x109/L or APTT >50 sec
    • Serious concurrent medical illness: myocardial infarction, seizures, sepsis, uncontrolled diabetes, uncontrolled hypertension, brain tumor, renal impairment (eGFR \<60).
    • Baseline glucose \< 2.7 or > 22.2 mmol/L
    • Imaging features of:

      • raised intracranial pressure or significant mass effect (for example, midline shift, severe sulcal effacement, transcompartmental herniation)
      • intracranial hemorrhage
      • vascular malformation or aneurysm
      • significant vascular abnormality such as carotid dissection, complete carotid occlusion or large/medium vessel vasculitis
    • Allergy/sensitivity to nickel-titanium or contrast media
    • Females who are pregnant or lactating
    • Unable to obtain informed consent from the patient or a suitable legal representative
    • Any other contraindication to thrombectomy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Tigertriever

    Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.

    Device: Tigertriever

Interventions

  • DeviceTigertriever

    Mechanical Thrombectomy

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What researchers measure

Primary outcomes

  1. Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.

    Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.

    Time frame: 24 hours post procedure

  2. Percentage of participants with a new occlusion.

    Safety Endpoints.

    Time frame: Day 0 (end of procedure)

  3. Percentage of participants with a TICI Score ≥IIb post procedure.

    Effectiveness Endpoints

    Time frame: Day 0 (end of procedure)

  4. Percentage of participants with a TICI Score ≥IIb post procedure after first pass.

    Effectiveness Endpoints

    Time frame: Day 0 (end of procedure)

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Study locations

1 site
  • Imperial College Healthcare
    London, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03871309
Lead sponsor
Rapid Medical
Responsible party
Sponsor
First posted
Mar 12, 2019
Start date
Feb 7, 2020
Primary completion
Aug 4, 2022
Completion
Oct 10, 2023
Last update
Apr 12, 2024

Study contacts

Kyri Lobotesis, MD
principal investigator · Imperial College Healthcare

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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