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CompletedNCT00318071Multi-MERCIUpdated Nov 7, 2014

Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

An interventional study of Merci Retriever in Ischemic Stroke, sponsored by Stryker Neurovascular. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-07.

Sponsored by Stryker Neurovascular · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Ischemic Stroke

Keywords

  • Stroke
  • Ischemic
  • Thrombus
  • Embolectomy
  • Thrombectomy
  • Merci
  • Concentric
  • Embolus
  • Embolism
  • Mechanical
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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 164 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Stryker Neurovascular is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    Treatment

    Treatment arm patients had at least one Merci Retriever deployed

    Device: Merci Retriever

Interventions

  • DeviceMerci Retriever

    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.

06

What researchers measure

Primary outcomes

  1. Revascularization success; Rates of device-related serious adverse events

    Time frame: post-procedure

Secondary outcomes

  1. modified Rankin scores

    Time frame: 90-day

  2. mortality

    Time frame: 90-day

  3. Symptomatic hemorrhage rate

    Time frame: 24 hour post procedure

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Study locations

No study locations are listed for this record.

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References and documents

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 18309168 ↗
  • Smith 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 16775259 ↗
  • Flint 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 17332445 ↗
  • Lutsep 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 18346645 ↗
  • Shi 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 24876082 ↗
  • Liebeskind 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00318071
Lead sponsor
Stryker Neurovascular
Responsible party
Sponsor
First posted
Apr 26, 2006
Start date
Jan 2004
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Nov 7, 2014

Study contacts

Wade S Smith, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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