Ischemic StrokePROMISENCT02678169
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Penumbra Inc. at 1 site in Germany.
Trial summary
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Penumbra Aspiration System
- Type of treatment
- Medical device
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Nov 2017
- 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: Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset. Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)
Who may be able to join
- General inclusion criteria:
- From 18 years of age
- Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset
- Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)
- National Institute of Health Stroke Scale (NIHSS) ≥ 2
- Signed Informed Consent Form.
- Imaging inclusion criteria:
- CT ASPECT score from 6 to 10 (>6) or according to MR DWI ASPECT score from 5 to 10 (>5).
Who cannot join
- General exclusion criteria:
- Associated myocardial infarction or severe infection (endocarditis or sepsis)
- Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT > 50 sec
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
- Baseline glucose < 2.7 or > 22.2 mmol/L
- Pre-stroke mRS score > 2
Show all 18Show fewer
- Seizure at the onset of stroke
- Arterial tortuosity that would prevent the device from reaching the target vessel
- Time of stroke symptoms onset unknown
- Life expectancy less than 90 days prior to stroke onset
- Females who are pregnant or lactating
- Known serious sensitivity to radiographic contrast media.
- Imaging exclusion criteria:
- CT/MRI evidence of the following conditions at screening:
- Significant mass effect with midline shift
- Evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM)
- Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion.
- Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
Read the detailed description
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.
- Conditions
- Ischemic Stroke
- Being tested
- Penumbra Aspiration System
- 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 Aspiration SystemDevice
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
| Study group | Role | What they receive |
|---|---|---|
| Penumbra Aspiration System | Penumbra Aspiration System with the ADAPT technique Receives: Device: Penumbra Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score.
Measured: Immediate post-procedure
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.
Measured: 90 days post-procedure
Secondary outcomes (9)
Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment
Measured: 24 hours and 30 days from stroke treatment
All causes of mortality and morbidity at 90 days
Measured: 90 days
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Measured: At the end of interventional surgical procedure
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Measured: 24 hours
Occurrence of vessel damages at the end of the ADAPT procedure.
Measured: At the end of the interventional surgical procedure
NIHSS score at 7-10 days post-procedure.
Measured: 7-10 days post-procedure
Times to revascularization
- From symptom onset to CT-scan/MRI at the institution
- From CT-scan/MRI at the institution to groin access
- From groin puncture to final revascularization result.
Measured: From symptom onset to various times during the interventional surgical procedure
Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure.
Measured: 90 days
Heath Economics: Total duration of hospitalization with related healthcare resources
- Health care professionals encountered/consulted before/after intervention
- Tests performed before/after intervention.
Measured: Average time frame 3-7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Schramm, MD, Principal investigator, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678169
- Sponsor's protocol ID
- CLP 9508
- Acronym
- PROMISE
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schramm P, Navia P, Papa R, Zamarro J, Tomasello A, Weber W, Fiehler J, Michel P, Pereira VM, Krings T, Gralla J, Santalucia P, Pierot L, Lo TH. ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. J Neurointerv Surg. 2019 Mar;11(3):226-231. doi: 10.1136/neurintsurg-2018-014122. Epub 2018 Jul 30.
PubMed 30061367Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20.
PubMed 28428348
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02678169
- Acronym / sponsor ID
- PROMISE / CLP 9508
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
Detailed description
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penumbra Aspiration System | – | Device: Penumbra Aspiration SystemPenumbra Aspiration System with the ADAPT technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset. Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)
Key inclusion criteria (8 listed)
- General inclusion criteria:
- CT ASPECT score from 6 to 10 (>6) or according to MR DWI ASPECT score from 5 to 10 (>5).
Key exclusion criteria (18 listed)
- General exclusion criteria:
- CT/MRI evidence of the following conditions at screening:
- Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion.
- Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
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 Aspiration SystemPenumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain | Device | Penumbra Aspiration System |
Primary outcome
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score.
Time frame: Immediate post-procedure
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.
Time frame: 90 days post-procedure
9 secondary outcomes
Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment
Time frame: 24 hours and 30 days from stroke treatment
All causes of mortality and morbidity at 90 days
Time frame: 90 days
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Time frame: At the end of interventional surgical procedure
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Time frame: 24 hours
Occurrence of vessel damages at the end of the ADAPT procedure.
Time frame: At the end of the interventional surgical procedure
NIHSS score at 7-10 days post-procedure.
Time frame: 7-10 days post-procedure
Times to revascularization
Time frame: From symptom onset to various times during the interventional surgical procedure
Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure.
Time frame: 90 days
Heath Economics: Total duration of hospitalization with related healthcare resources
Time frame: Average time frame 3-7 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 17 Jan 2018.
- Derived from this study: PubMed 30061367Schramm P, Navia P, Papa R, Zamarro J, Tomasello A, Weber W, Fiehler J, Michel P, Pereira VM, Krings T, Gralla J, Santalucia P, Pierot L, Lo TH. ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. J Neurointerv Surg. 2019 Mar;11(3):226-231. doi: 10.1136/neurintsurg-2018-014122. Epub 2018 Jul 30.
- Derived from this study: PubMed 28428348Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20.
- Individual participant dataSharing planned: No
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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.
Peter Schramm, MD principal investigator
Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Penumbra Inc. at 1 site in Germany.
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 8 inclusion and 18 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. (time frame: Immediate post-procedure). The study lists 2 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 NCT02678169, which also lists 2 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 17 Jan 2018.