Clinical trial NCT03871309: Tigertriever Distal Vessels Registry
Official title: Tigertriever Distal Vessels Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Lead sponsor: Rapid Medical
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
timeFrame: 24 hours post procedure
measure: Percentage of participants with a new occlusion.
timeFrame: Day 0 (end of procedure)
measure: Percentage of participants with a TICI Score ≥IIb post procedure.
timeFrame: Day 0 (end of procedure)
measure: Percentage of participants with a TICI Score ≥IIb post procedure after first pass.
timeFrame: Day 0 (end of procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare
Study officials:
affiliation: Imperial College Healthcare
name: Kyri Lobotesis, MD
role: PRINCIPAL_INVESTIGATOR
References: