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

NCT00318071 | Completed DMC

• 1 other identifier: INT-LR-001
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic; Thrombus; Embolectomy; Thrombectomy; Merci; Concentric; Embolus; Embolism; Mechanical

Outcome Measures

Primary Outcomes (1)

• Revascularization success; Rates of device-related serious adverse events

  post-procedure

Secondary Outcomes (3)

• modified Rankin scores

  90-day

• mortality

  90-day

• Symptomatic hemorrhage rate

  24 hour post procedure

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment arm patients had at least one Merci Retriever deployed

Device: Merci Retriever

Interventions

Merci Retriever DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Related Publications (6)

• 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.

  PMID: 18309168 RESULT

• 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.

  PMID: 16775259 RESULT

• 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.

  PMID: 17332445 RESULT

• 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.

  PMID: 18346645 RESULT

• 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.

  PMID: 24876082 DERIVED

• 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.

  PMID: 24789707 DERIVED

Related Links

• Concentric Medical Website

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia; Thrombosis; Embolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• Wade S Smith, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2005
• First Posted: April 26, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 7, 2014

Record last verified: 2014-11