Trial Outcomes & Findings for Imaging Guided Patient Selection for Interventional Revascularization Therapy (NCT NCT00963989)

NCT ID: NCT00963989

Last Updated: 2021-11-23

Results Overview

Modified Rankin Scale (mRS) ranges from 0 to 5, with higher scores being worse.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 146 participants
• Primary outcome timeframe: At 90 days post-procedure
• Results posted on: 2021-11-23

Participant Flow

Participant milestones

Measure	Penumbra Device Arm Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Overall Study STARTED	146
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Guided Patient Selection for Interventional Revascularization Therapy

Baseline characteristics by cohort

Measure	Penumbra Device Arm n=146 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Age, Continuous	66 Years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Baseline NIHSS	19 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: At 90 days post-procedure

Population: 16 subjects with missing 90-day mRS assessment and 3 withdrew consent.

Modified Rankin Scale (mRS) ranges from 0 to 5, with higher scores being worse.

Outcome measures

Measure	Penumbra Device Arm n=127 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure	57 Participants

PRIMARY outcome

Timeframe: At immediate post-procedure

Population: One subject had two sites of occlusion

Defined by Number of participants with Thrombolysis in Myocardial Infarction (TIMI) 2-3.

A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.

Outcome measures

Measure	Penumbra Device Arm n=147 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Angiographic Assessment of Vessel Patency as Measured by TIMI Score	122 Participants

PRIMARY outcome

Timeframe: At immediate post-procedure

Population: One subject had two sites of occlusion

Defined by number of participants with modified thrombolysis in cerebral infarction (TICI) 2-3.

A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.

Outcome measures

Measure	Penumbra Device Arm n=147 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score	122 Participants

PRIMARY outcome

Timeframe: During the procedure, approximately 24 hours

Defined by serious adverse events (SAEs) within 24 hours of the procedure

Outcome measures

Measure	Penumbra Device Arm n=146 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Procedural Serious Adverse Events During the Procedure	40 events

SECONDARY outcome

Timeframe: At Discharge, an average of 7 days

Outcome measures

Measure	Penumbra Device Arm n=112 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Good Neurological Recovery Post-procedure as Defined by a 10 Points or More Improvement on the NIHSS at Discharge	47 Participants

SECONDARY outcome

Timeframe: Within 24 hours of the procedure

Outcome measures

Measure	Penumbra Device Arm n=146 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Incidence of Symptomatic and Asymptomatic Hemorrhage Based on the ECASS Criteria and Patient Neurological Status Within 24 Hours of the Procedure	18 Participants

SECONDARY outcome

Timeframe: At 90 days post-procedure

Outcome measures

Measure	Penumbra Device Arm n=146 Participants Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
All Cause Mortality at 90 Days Post-procedure	37 Participants

Adverse Events

Penumbra Device Arm

Serious events: 8 serious events

Other events: 14 other events

Deaths: 37 deaths

Serious adverse events

Measure	Penumbra Device Arm n=146 participants at risk Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
Nervous system disorders Carotid artery dissection	0.68% 1/146
Nervous system disorders Cerebral artery occlusion	0.68% 1/146
Nervous system disorders Cerebral haemorrhage	0.68% 1/146
Nervous system disorders Cerebral vasoconstriction	0.68% 1/146
Nervous system disorders Haemorrhagic transformation stroke	0.68% 1/146
Nervous system disorders Ischaemic cerebral infarction	0.68% 1/146
Vascular disorders Vessel perforation	1.4% 2/146

Other adverse events

Measure	Penumbra Device Arm n=146 participants at risk Penumbra System: The Penumbra System is used to revascularize clotted cerebral blood vessels.
General disorders Infusion site extravasation	0.68% 1/146
Nervous system disorders Cerebral artery embolism	0.68% 1/146
Nervous system disorders Cerebral haematoma	0.68% 1/146
Nervous system disorders Cerebral haemorrhage	1.4% 2/146
Nervous system disorders Cerebral vasoconstriction	4.8% 7/146
Nervous system disorders Haemorrhagic transformation stroke	0.68% 1/146
Nervous system disorders Vascular dissection	0.68% 1/146

Additional Information

Director of Clinical Affairs

Penumbra, Inc.

Phone: +1 510 995 2183

Email: blawson@penumbrainc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place