Ischemic StrokeMulti-MERCINCT00318071
Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
A study testing Merci Retriever in people with Ischemic Stroke, run by Stryker Neurovascular.
Trial summary
The primary objectives of the Multi MERCI trial were: to evaluate the addition of the Merci L5 Retriever additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted) 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?
- Merci Retriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2006
- Phase
- Interventional
- 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
Who may be able to join
- Angiographically confirmed large vessel ischemic stroke (occlusion may include the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries)
- Intervention is able to be performed within 8 hours of symptom onset
- Patients > 18 years of age
- NIHSS score 8+
- Failed IV t-PA treatment or contraindicated for IV t-PA
Who cannot join
- International Normalized Ratio (INR) > 3.0
- Platelet count < 30,000
- Heparin use in previous 24 hours with PTT > 2X normal
- Baseline bloog glucose < 50 mg/dL
- Baseline computed tomography (CT) showing mass effect with midline shift
- Severe sustained hypertension (SBP > 185 or DBP > 110) that cannot be controlled with medication
Show all 9Show fewer
- Patient is pregnant, has anticipated life expectancy < 3 months, or has severe allergy to contrast medium
- Arterial stenosis > 50% proximal to embolus
- Excessive arterial tortuosity that precludes the study device from reaching the target area
About this study
Official title: A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
The primary objectives of the Multi MERCI trial were:
- to evaluate the addition of the Merci L5 Retriever
- additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted)
Read the detailed description
Per the Multi MERCI protocol, up to 230 patients could be treated at up to 30 centers.
The intended trial indication for the Merci L5 Retriever was to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients that were contraindicated or failed treatment with intravenous t-PA were allowed to be enrolled under the Multi MERCI protocol.
Per the Multi MERCI protocol, following inclusion of the Merci L5 Retriever the operating physician was required to initiate treatment with the Merci L5 Retriever. At the physician's discretion, subsequent passes could be made with the Merci L5 Retriever, Merci X6 Retriever and/or Merci X5 Retriever.
Adverse events were adjudicated by an independent Data Safety and Monitoring Board (Capital DSMB).
- Conditions
- Ischemic Stroke
- Being tested
- Merci Retriever
- 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.
Merci RetrieverDevice
For patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers.
Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries.
Recanalization was defined as TIMI II or TIMI III per angiography.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment arm patients had at least one Merci Retriever deployed Receives: Device: Merci Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization success; Rates of device-related serious adverse events
Measured: post-procedure
Secondary outcomes (3)
modified Rankin scores
Measured: 90-day
mortality
Measured: 90-day
Symptomatic hemorrhage rate
Measured: 24 hour post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 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, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318071
- Sponsor's protocol ID
- INT-LR-001
- Acronym
- Multi-MERCI
- Status last verified
- Nov 2014
- First submitted
- 14 Jul 2005
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators; Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28.
PubMed 18309168Smith WS. Safety of mechanical thrombectomy and intravenous tissue plasminogen activator in acute ischemic stroke. Results of the multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial, part I. AJNR Am J Neuroradiol. 2006 Jun-Jul;27(6):1177-82.
PubMed 16775259Flint AC, Duckwiler GR, Budzik RF, Liebeskind DS, Smith WS; MERCI and Multi MERCI Writing Committee. Mechanical thrombectomy of intracranial internal carotid occlusion: pooled results of the MERCI and Multi MERCI Part I trials. Stroke. 2007 Apr;38(4):1274-80. doi: 10.1161/01.STR.0000260187.33864.a7. Epub 2007 Mar 1.
PubMed 17332445Lutsep HL, Rymer MM, Nesbit GM. Vertebrobasilar revascularization rates and outcomes in the MERCI and multi-MERCI trials. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):55-7. doi: 10.1016/j.jstrokecerebrovasdis.2007.11.003.
PubMed 18346645Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.
PubMed 24876082Liebeskind DS, Flint AC, Budzik RF, Xiang B, Smith WS, Duckwiler GR, Nogueira RG; MERCI and Multi-MERCI Investigators. Carotid I's, L's and T's: collaterals shape the outcome of intracranial carotid occlusion in acute ischemic stroke. J Neurointerv Surg. 2015 Jun;7(6):402-7. doi: 10.1136/neurintsurg-2014-011231. Epub 2014 May 1.
PubMed 24789707
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
- ClinicalTrials.gov ID
- NCT00318071
- Acronym / sponsor ID
- Multi-MERCI / INT-LR-001
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Apr 2006 (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.
The primary objectives of the Multi MERCI trial were:
- to evaluate the addition of the Merci L5 Retriever
- additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted)
Detailed description
Per the Multi MERCI protocol, up to 230 patients could be treated at up to 30 centers.
The intended trial indication for the Merci L5 Retriever was to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients that were contraindicated or failed treatment with intravenous t-PA were allowed to be enrolled under the Multi MERCI protocol.
Per the Multi MERCI protocol, following inclusion of the Merci L5 Retriever the operating physician was required to initiate treatment with the Merci L5 Retriever. At the physician's discretion, subsequent passes could be made with the Merci L5 Retriever, Merci X6 Retriever and/or Merci X5 Retriever.
Adverse events were adjudicated by an independent Data Safety and Monitoring Board (Capital DSMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Merci RetrieverTreatment arm patients had at least one Merci Retriever deployed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Angiographically confirmed large vessel ischemic stroke (occlusion may include the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries)
- Intervention is able to be performed within 8 hours of symptom onset
- Patients > 18 years of age
- NIHSS score 8+
- Failed IV t-PA treatment or contraindicated for IV t-PA
Key exclusion criteria (9 listed)
- International Normalized Ratio (INR) > 3.0
- Platelet count < 30,000
- Heparin use in previous 24 hours with PTT > 2X normal
- Baseline bloog glucose < 50 mg/dL
- Baseline computed tomography (CT) showing mass effect with midline shift
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 |
|---|---|---|
| Merci RetrieverFor patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers. Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries. Recanalization was defined as TIMI II or TIMI III per angiography. | Device | Treatment |
Primary outcome
Revascularization success; Rates of device-related serious adverse events
Time frame: post-procedure
3 secondary outcomes
modified Rankin scores
Time frame: 90-day
mortality
Time frame: 90-day
Symptomatic hemorrhage rate
Time frame: 24 hour post procedure
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 7 Nov 2014.
- Results publication: PubMed 18309168Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators; Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28.
- Results publication: PubMed 16775259Smith WS. Safety of mechanical thrombectomy and intravenous tissue plasminogen activator in acute ischemic stroke. Results of the multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial, part I. AJNR Am J Neuroradiol. 2006 Jun-Jul;27(6):1177-82.
- Results publication: PubMed 17332445Flint AC, Duckwiler GR, Budzik RF, Liebeskind DS, Smith WS; MERCI and Multi MERCI Writing Committee. Mechanical thrombectomy of intracranial internal carotid occlusion: pooled results of the MERCI and Multi MERCI Part I trials. Stroke. 2007 Apr;38(4):1274-80. doi: 10.1161/01.STR.0000260187.33864.a7. Epub 2007 Mar 1.
- Results publication: PubMed 18346645Lutsep HL, Rymer MM, Nesbit GM. Vertebrobasilar revascularization rates and outcomes in the MERCI and multi-MERCI trials. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):55-7. doi: 10.1016/j.jstrokecerebrovasdis.2007.11.003.
- Derived from this study: PubMed 24876082Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.
- Derived from this study: PubMed 24789707Liebeskind DS, Flint AC, Budzik RF, Xiang B, Smith WS, Duckwiler GR, Nogueira RG; MERCI and Multi-MERCI Investigators. Carotid I's, L's and T's: collaterals shape the outcome of intracranial carotid occlusion in acute ischemic stroke. J Neurointerv Surg. 2015 Jun;7(6):402-7. doi: 10.1136/neurintsurg-2014-011231. Epub 2014 May 1.
- Concentric Medical WebsiteLink 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, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Merci Retriever in people with Ischemic Stroke, run by Stryker Neurovascular.
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 9 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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Revascularization success; Rates of device-related serious adverse events (time frame: post-procedure). 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 NCT00318071, which also lists 6 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 7 Nov 2014.