Ischemic StrokeNCT00478478
Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Stryker Neurovascular at 1 site in United States.
Trial summary
Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include: Post-procedure revascularization success 90-day mRS 0-2 90-day mortality Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with ischemic stroke treated with a Merci Retriever either alone or in combination with adjunctive therapies such as lytics will be included in the Registry.
Who may be able to join
- Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. "Treated" is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke
- Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place
Who cannot join
- -There are no exclusion criteria for this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Brain and Stroke Institute
Kansas City, Missouri, 64111
About this study
Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:
- Post-procedure revascularization success
- 90-day mRS 0-2
- 90-day mortality
Read the detailed description
The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.
The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Keywords
- Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus, Embolism, Mechanical
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia, Thrombosis, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyProcedure or surgery
Also called Merci Retrieval System
Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke patients | Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Mechanical Thrombectomy procedure. Receives: Procedure: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedure revascularization success
Measured: post-procedure
Secondary outcomes (3)
NIHSS change from baseline to 24-hours
Measured: 24-hour
90-day mRS outcomes
Measured: 90-day
90-day mortality
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wade S Smith, MD, PhD, Principal investigator, University of California at San Francisco, SF, CAMarilyn M Rymer, MD, Principal investigator, MABSI St. Luke's, Kansas City, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478478
- Sponsor's protocol ID
- INT-REG-001
- Status last verified
- Nov 2014
- First submitted
- 22 May 2007
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00478478
- Acronym / sponsor ID
- INT-REG-001
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 May 2007 (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.
Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:
- Post-procedure revascularization success
- 90-day mRS 0-2
- 90-day mortality
Detailed description
The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.
The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke patients | – | Procedure: Mechanical ThrombectomyPatients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Mechanical Thrombectomy procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with ischemic stroke treated with a Merci Retriever either alone or in combination with adjunctive therapies such as lytics will be included in the Registry.
Key inclusion criteria (2 listed)
- Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. "Treated" is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke
- Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place
Key exclusion criteria (1 listed)
- -There are no exclusion criteria for this protocol
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 |
|---|---|---|
| Mechanical ThrombectomyAlso: Merci Retrieval SystemThrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke. | Procedure or surgery | Acute Ischemic Stroke patients |
Primary outcome
Post-procedure revascularization success
Time frame: post-procedure
3 secondary outcomes
NIHSS change from baseline to 24-hours
Time frame: 24-hour
90-day mRS outcomes
Time frame: 90-day
90-day mortality
Time frame: 90-day
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 10 Nov 2014.
- Stryker NeurovascularLink provided by the sponsor.
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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.
Wade S Smith, MD, PhD principal investigator
University of California at San Francisco, SF, CA
Marilyn M Rymer, MD principal investigator
MABSI St. Luke's, Kansas City, MO
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 Stryker Neurovascular at 1 site in United States.
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 2 inclusion and 1 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 10 Nov 2014. 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 United States. 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?
Post-procedure revascularization success (time frame: post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2014.