Trial Outcomes & Findings for Study to Assess the Safety and Effectiveness of the Penumbra System (NCT NCT00334061)
NCT ID: NCT00334061
Last Updated: 2019-09-18
Results Overview
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
COMPLETED
PHASE2
125 participants
3-Month Post-Procedure
2019-09-18
Participant Flow
From June 19, 2006 to June 5, 2007 a total of 856 patients were screened of which 125 patients were enrolled at 24 centers in Europe and the United States.
Participant milestones
| Measure |
Penumbra System
|
|---|---|
|
Overall Study
STARTED
|
125
|
|
Overall Study
COMPLETED
|
125
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Safety and Effectiveness of the Penumbra System
Baseline characteristics by cohort
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
71 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-Month Post-ProcedurePopulation: Intention to Treat
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
Outcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With Revascularization of the Occluded Target Vessel
|
81.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: 3-Month Post-ProcedurePopulation: All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.
Outcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
|
2.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Discharge or 30-Days Post-ProcedureNIHSS is a 42 point scale to describe the neurological status of the patients: 0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Outcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment
|
41.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: 90-DayThe mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Outcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
|
25 Percentage of Participants
|
SECONDARY outcome
Timeframe: 90-Days Post-TreatmentOutcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With All Cause Mortality
|
32.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: 24-Hour Post-ProcedureAll treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.
Outcome measures
| Measure |
Penumbra System
n=125 Participants
|
|---|---|
|
Percentage of Participants With Symptomatic Hemorrhage
|
11.2 Percentage of Participants
|
Adverse Events
Penumbra System
Serious adverse events
| Measure |
Penumbra System
n=125 participants at risk
|
|---|---|
|
Nervous system disorders
Cerebral Edema
|
11.2%
14/125
|
|
Nervous system disorders
Intracerebral Hemorrhage
|
8.0%
10/125
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Dysfunction/Failure
|
8.0%
10/125
|
|
Nervous system disorders
Worsening Symptoms of Qualifying Stroke
|
7.2%
9/125
|
|
General disorders
Infection
|
5.6%
7/125
|
|
Respiratory, thoracic and mediastinal disorders
Other Pulmonary Complications
|
5.6%
7/125
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
5/125
|
|
Cardiac disorders
Cardiac Arrhythmia
|
3.2%
4/125
|
|
Skin and subcutaneous tissue disorders
Access Site Complication
|
2.4%
3/125
|
|
Cardiac disorders
Myocardial Infarction
|
2.4%
3/125
|
|
Vascular disorders
Peripheral Vascular Complication
|
2.4%
3/125
|
|
Renal and urinary disorders
Renal Dysfunction/Failure
|
2.4%
3/125
|
|
Nervous system disorders
Stroke in New Territory
|
2.4%
3/125
|
Other adverse events
| Measure |
Penumbra System
n=125 participants at risk
|
|---|---|
|
Infections and infestations
Infection
|
24.8%
31/125
|
|
Infections and infestations
Pneumonia
|
18.4%
23/125
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
17.6%
22/125
|
|
General disorders
Pain
|
16.8%
21/125
|
|
General disorders
Fever
|
11.2%
14/125
|
|
Blood and lymphatic system disorders
Anemia
|
10.4%
13/125
|
|
Cardiac disorders
Cardiac Arrhythmia
|
10.4%
13/125
|
|
Injury, poisoning and procedural complications
Cerebral Edema
|
9.6%
12/125
|
|
Respiratory, thoracic and mediastinal disorders
Other Pulmonary Complications
|
9.6%
12/125
|
|
Hepatobiliary disorders
Hyperglycemia
|
8.0%
10/125
|
|
Vascular disorders
Hypotension
|
7.2%
9/125
|
|
Gastrointestinal disorders
Nausea
|
7.2%
9/125
|
|
Nervous system disorders
Headache
|
6.4%
8/125
|
|
Vascular disorders
Peripheral Vascular Complication
|
6.4%
8/125
|
|
Gastrointestinal disorders
Constipation
|
5.6%
7/125
|
|
Renal and urinary disorders
Renal Dysfunction/Failure
|
5.6%
7/125
|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.0%
5/125
|
|
Psychiatric disorders
Depression
|
4.0%
5/125
|
|
Hepatobiliary disorders
Hepato-Biliary Dysfunction
|
4.0%
5/125
|
|
Metabolism and nutrition disorders
Peripheral Edema
|
4.0%
5/125
|
|
Nervous system disorders
Worsening Symptoms of Qualifying Stroke
|
4.0%
5/125
|
|
Psychiatric disorders
Dysphasia-Aspiration
|
3.2%
4/125
|
|
Vascular disorders
Hypertension
|
3.2%
4/125
|
|
Vascular disorders
Peripheral Hemorrhage
|
3.2%
4/125
|
|
Psychiatric disorders
Anxiety
|
2.4%
3/125
|
|
Cardiac disorders
Cardiac Complications
|
2.4%
3/125
|
|
Psychiatric disorders
Confusion
|
2.4%
3/125
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
2/125
|
|
Vascular disorders
Embolization of Previously Uninvolved Vessel
|
1.6%
2/125
|
|
Gastrointestinal disorders
GERD
|
1.6%
2/125
|
|
Nervous system disorders
Seizure
|
1.6%
2/125
|
|
General disorders
Ulcer
|
1.6%
2/125
|
|
General disorders
Other
|
12.8%
16/125
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60