Trial Outcomes & Findings for Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke (NCT NCT01869478)

Results Overview

The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

24 hours

Results posted on

2016-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Thrombolysis 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.	Endovascular Arterial Reperfusion Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of IV Recombinant Tissue Plasminogen Activator (rtPA) vs. Primary Endovascular Therapy for Acute Ischemic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Thrombolysis 0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.	Endovascular Arterial Reperfusion n=1 Participants Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Only one participant was enrolled, so data analysis was not possible.

The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Population: Only one participant was enrolled, so data analysis was not possible.

Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Thrombolysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endovascular Arterial Reperfusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin M. Barrett, MD

Mayo Clinic

Phone: 904-953-9740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place