Trial Outcomes & Findings for Treatment With Intent to Generate Endovascular Reperfusion (NCT NCT03474549)

NCT ID: NCT03474549

Last Updated: 2024-05-08

Results Overview

Effectiveness (Successful reperfusion)

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

Day 0 (end of procedure)

Results posted on

2024-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Tigertriever Revascularization Device Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Overall Study STARTED	160
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Tigertriever Revascularization Device Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Overall Study Death	31
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Treatment With Intent to Generate Endovascular Reperfusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tigertriever Revascularization Device n=160 Participants Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Age, Continuous	65.5 years STANDARD_DEVIATION 13.9 • n=99 Participants
Sex: Female, Male Female	68 Participants n=99 Participants
Sex: Female, Male Male	92 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	24 Participants n=99 Participants
Race (NIH/OMB) White	134 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Day 0 (end of procedure)

Population: main study cohort (post lead-in)- 117 overall patients (including lead-in)- 160

Effectiveness (Successful reperfusion)

Outcome measures

Outcome measures
Measure	Tigertriever Revascularization Device n=160 Participants Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Successful Reperfusion, Defined as mTICI Score ≥ 2b	130 Participants

PRIMARY outcome

Timeframe: 90 days post treatment

Population: main study cohort (post lead-in)- 117 all patients (including lead-in)- 160

Safety (All-cause mortality)

Outcome measures

Outcome measures
Measure	Tigertriever Revascularization Device n=160 Participants Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
All-cause Mortality	31 Participants

PRIMARY outcome

Timeframe: 24 hours post procedure

Population: main study cohort (post lead-in)- 117 overall patients (including lead-in)- 160

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.

Outcome measures

Outcome measures
Measure	Tigertriever Revascularization Device n=160 Participants Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
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	3 Participants

SECONDARY outcome

Timeframe: 90 days post treatment

Population: Sample sizes vary due to missing data at 90 days.

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.

Outcome measures

Outcome measures
Measure	Tigertriever Revascularization Device n=154 Participants Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Modified Rankin Scale (mRS) Score of ≤2	86 Participants

Adverse Events

Tigertriever Revascularization Device

Serious events: 71 serious events

Other events: 120 other events

Deaths: 31 deaths

Serious adverse events

Serious adverse events
Measure	Tigertriever Revascularization Device n=160 participants at risk Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Cardiac disorders Cardiac disorders	9.4% 15/160 • 90 days
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.9% 3/160 • 90 days
Gastrointestinal disorders Gastrointestinal disorders	2.5% 4/160 • 90 days
General disorders General disorders and administration site conditions	1.2% 2/160 • 90 days
Infections and infestations Infections and infestations	3.1% 5/160 • 90 days
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	3.8% 6/160 • 90 days
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.62% 1/160 • 90 days
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders\|Psychiatric disorders	0.62% 1/160 • 90 days
Nervous system disorders Nervous system disorders	10.6% 17/160 • 90 days
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	2.5% 4/160 • 90 days
Surgical and medical procedures Surgical and medical procedures	0.62% 1/160 • 90 days
Vascular disorders Vascular disorders	7.5% 12/160 • 90 days

Other adverse events

Other adverse events
Measure	Tigertriever Revascularization Device n=160 participants at risk Mechanical thrombectomy with Tigertriever Tigertriever revascularization device: Mechanical Thrombectomy
Blood and lymphatic system disorders Blood and lymphatic system disorders	10.0% 16/160 • Number of events 16 • 90 days
Cardiac disorders Cardiac disorders	13.1% 21/160 • Number of events 21 • 90 days
Ear and labyrinth disorders Ear and labyrinth disorders	0.62% 1/160 • 90 days
Gastrointestinal disorders Gastrointestinal disorders	11.2% 18/160 • 90 days
General disorders General disorders and administration site conditions	3.1% 5/160 • 90 days
Infections and infestations Infections and infestations	4.4% 7/160 • 90 days
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	3.1% 5/160 • 90 days
Investigations Investigations	1.2% 2/160 • 90 days
Metabolism and nutrition disorders Metabolism and nutrition disorders	3.8% 6/160 • 90 days
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	3.1% 5/160 • 90 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1.2% 2/160 • 90 days
Nervous system disorders Nervous system disorders	11.2% 18/160 • 90 days
Renal and urinary disorders Renal and urinary disorders	1.9% 3/160 • 90 days
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.62% 1/160 • 90 days
Surgical and medical procedures Surgical and medical procedures	0.62% 1/160 • 90 days
Vascular disorders Vascular disorders	5.6% 9/160 • 90 days

Additional Information

Dr. Walid Haddad- Chief Clinical Officer

Rapid-Medical

Phone: +972 72 2503331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place