Stroke, IschemicNCT03464565
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
An observational study of Stroke, Ischemic, run by Penumbra Inc. at 42 sites in 6 countries.
Trial summary
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Penumbra System
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 42 sitesin 6 countries
- Study dates
- 2 Jul 2018to 17 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Who may be able to join
- Patient age ≥ 18
- Pre-stroke mRS 0-1
- Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
- Planned frontline treatment with Penumbra System
- Signed informed consent per Institution Review Board/Ethics Committee
Who cannot join
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
- Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
United States29 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Eden Medical Center
Castro Valley, California, 94546
Erlanger Health System
Chattanooga, Tennessee, 37403
Palmetto Health Richland Hospital
Columbia, South Carolina, 29203
RIA
Englewood, Colorado, 80112
St. Jude Medical Center
Fullerton, California, 92835
Valley Baptist Medical Center
Harlingen, Texas, 78550
Houston Methodist Hospital
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66106
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
Cedar Sinai Medical Center
Los Angeles, California, 90048
Northwell Health
Manhasset, New York, 11042
McAllen Medical Center
McAllen, Texas, 78503
Methodist University Hospital
Memphis, Tennessee, 38104
Banner Desert Medical Center
Mesa, Arizona, 85202
Jackson Memorial Hospital
Miami, Florida, 33136
Naples Community Hospital
Naples, Florida, 34102
Yale New Haven Hospital
New Haven, Connecticut, 06519
Oschner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai New York
New York, New York, 10029
NYU Langone Hospital-Brooklyn
New York, New York, 11220
AdventHealth Orlando
Orlando, Florida, 32803
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
The Valley Hospital
Ridgewood, New Jersey, 07450
Mercy San Juan Medical Center
Sacramento, California, 95608
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122
SSM St. Clare Healthcare
St Louis, Missouri, 63026
Los Robles Hospital
Thousand Oaks, California, 91360
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
Germany5 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23538
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, 39120
Russia3 sites
Davidovsky Moscow City Hospital №23
Moscow, 109240
City Clinical Hospital No. 1
Moscow, 119049
Multidisciplinary City Hospital №2
Saint Petersburg, 194354
France2 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Foundation Ophthalmic Adolphe De Rothschild
Paris, 75019
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
About this study
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Read the detailed description
Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.
Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
- Conditions
- Stroke, Ischemic
- Being tested
- Penumbra System
- Keywords
- Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy, Penumbra System, 3D Revascularization
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra SystemDevice
Penumbra System
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke secondary to LVO | Not described Receives: Device: Penumbra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
mTICI Score
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher.
mTICI scale ranges 0 to 3 higher values represent better outcomes.
Measured: Post Procedure
Functional Subject Outcome
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2.
mRS scale ranges 0 to 6 higher values represent a worse outcome.
Measured: 90 days post
All-cause mortality at 90 days
All-cause mortality at 90 days
Measured: 90 days
Secondary outcomes (6)
Incidence of device and procedure related Serious Adverse Events (SAEs)
Measured: Within 24 hours of procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT)
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Measured: During Procedure
Occurrence of symptomatic intracranial hemorrhages (sICH)
Measured: 24 Hours Post Procedure
Time to Revascularization
Measured: During Procedure
Length of hospital stay
Measured: Through discharge, up to study completion at approximately 90 days
Discharge Facility
Measured: Through discharge, up to study completion at approximately 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start2 Jul 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osama O Zaidat, MD, Principal investigator, Mercy St. Vincent Medical CenterJohanna Fifi, MD, Principal investigator, Mount Sinai Health SystemAmeer E. Hassan, MD, Principal investigator, McAllen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464565
- Sponsor's protocol ID
- 12965
- Status last verified
- Dec 2020
- First submitted
- 7 Mar 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hassan AE, Fifi JT, Zaidat OO. Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry. Front Neurol. 2023 Sep 14;14:1239640. doi: 10.3389/fneur.2023.1239640. eCollection 2023.
PubMed 37794880Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022.
PubMed 36016541Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.
PubMed 34547927
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
- ClinicalTrials.gov ID
- NCT03464565
- Acronym / sponsor ID
- 12965
- Conditions
- Stroke, Ischemic
- Keywords
- Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy, Penumbra System, 3D Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Detailed description
Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.
Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke secondary to LVO | – | Device: Penumbra System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Key inclusion criteria (5 listed)
- Patient age ≥ 18
- Pre-stroke mRS 0-1
- Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
- Planned frontline treatment with Penumbra System
- Signed informed consent per Institution Review Board/Ethics Committee
Key exclusion criteria (2 listed)
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
- Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penumbra SystemPenumbra System | Device | Patients with acute ischemic stroke secondary to LVO |
Primary outcome
mTICI Score
Time frame: Post Procedure
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes.
Functional Subject Outcome
Time frame: 90 days post
Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome.
All-cause mortality at 90 days
Time frame: 90 days
All-cause mortality at 90 days
6 secondary outcomes
Incidence of device and procedure related Serious Adverse Events (SAEs)
Time frame: Within 24 hours of procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT)
Time frame: During Procedure
Occurrence of symptomatic intracranial hemorrhages (sICH)
Time frame: 24 Hours Post Procedure
Time to Revascularization
Time frame: During Procedure
Length of hospital stay
Time frame: Through discharge, up to study completion at approximately 90 days
Discharge Facility
Time frame: Through discharge, up to study completion at approximately 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 37794880Hassan AE, Fifi JT, Zaidat OO. Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry. Front Neurol. 2023 Sep 14;14:1239640. doi: 10.3389/fneur.2023.1239640. eCollection 2023.
- Derived from this study: PubMed 36016541Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022.
- Derived from this study: PubMed 34547927Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama O Zaidat, MD principal investigator
Mercy St. Vincent Medical Center
Johanna Fifi, MD principal investigator
Mount Sinai Health System
Ameer E. Hassan, MD principal investigator
McAllen Medical Center
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Penumbra Inc. at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Germany, Russia, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mTICI Score (time frame: Post Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464565, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.