Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke
ImpACT-1
Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
1 other identifier
interventional
98
1 country
2
Brief Summary
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation. The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedJuly 25, 2019
November 1, 2018
2.5 years
November 1, 2018
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment successful completion
The need to stop the treatment sessions completely or alternately.
5 Days
Adverse Events profile at 90 Day compared to VISTA trials data
Adverse Events profile at 90 days post implantation will be compared to the data retrieved form the VISTA trials.
90 Days
Secondary Outcomes (3)
The distribution of modified Rankin scale scores at 90 days
90 Days
NIHSS scores at 90 days
90 Days
Proportion of patients achieving a Barthel index at 90 days
90 Days
Other Outcomes (1)
Patient and treatment compliance to the stimulation
5 Days
Study Arms (1)
Active Stimulation
EXPERIMENTALThe Implant will be implanted using a minimal invasive approach. Following implantation, a CT localization imaging should be performed as soon as possible following the implant procedure. ISS (Ischemic Stroke System) stimulation of the SPG (Sphenopalatine Ganglionduring) for 5 consecutive days.
Interventions
Eligibility Criteria
You may qualify if:
- Age: ≥ 18 years and ≤ 85 of both genders
- Patients with symptoms and signs of an acute ischemic hemispheric stroke within the anterior circulation.
- NIHSS ≥ 7 and ≤ 20
- Treatment can be initiated within the first 24 hours following stroke onset or since last seen normal.
- Signed informed consent has been obtained from the patient him/herself or his/her legally authorized representative
You may not qualify if:
- Time interval since onset of symptoms undetermined
- Treatment with ISS500 System can't start within the first 24 hours post stroke onset
- Any other imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1-PH2) (H1 and H2 are allowed); or symptoms suspicious for sub-arachnoid hemorrhage, etc
- Clinical syndrome of an acute stroke due to lacunar infarct (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke), unless brain imaging demonstrates a relevant lesion \> 1.5 cm in size
- Not a stroke in the anterior circulation
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms with a high probably to Transient Ischemic Attack (TIA)
- Eligible to or treated with IV or IA t-PA or mechanical thrombolysis
- Baseline NIHSS \>20 or \< 7
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2)
- History of stroke in previous 6 months
- Pre-existing disability; Modified Rankin Score \> 2 upon screening
- Patients under oral anticoagulants or having received heparin within 48 hours, and / or with elevated activated partial thromboplastin time (aPTT) (or INR)
- High clinical suspicion of septic embolus
- Severe cardiac disease: evidence of congestive heart failure or has history of endstage cardiovascular disease (e.g. CHF NYHA Class III or IV or unstable angina)
- Uncontrolled hypertension upon enrollment (systolic \>185 mmHg and/or diastolic \>110 mmHg)
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BrainsGatelead
Study Sites (2)
Postgraduate Institute of Medical Education and Research
Chandigarh, India
Nizam's Institute of Medical Research Punjagutta, Hyderabad.
Hyderabad, India
Related Publications (1)
Khurana D, Kaul S, Schneider D, Csanyi A, Adam I, Ichaporia NR, Griewing B, Csiba L, Valikovics A, Puri V, Diener HC, Schwab S, Hetzel A, Bornstein N; ImpACT-1 Study Group. Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke. PLoS One. 2019 Jul 3;14(7):e0217472. doi: 10.1371/journal.pone.0217472. eCollection 2019.
PMID: 31269025DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subash Kaul, Dr.
Nizam's Institute of Medical Research Punjagutta, Hyderabad.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 7, 2018
Study Start
July 6, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
July 25, 2019
Record last verified: 2018-11