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

Ischemic Stroke Clinical Trial

— Multi-MERCI  

Official title:

A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318071
• Other study ID #: INT-LR-001
• Status: Completed
• Phase: N/A
• First received: July 14, 2005
• Last updated: November 6, 2014
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: November 2014
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemic Stroke

Intervention

Device:
• Merci 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

References & Publications (4)

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 — View Citation

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. — View Citation

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. Mechan — View Citation

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):1177-8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revascularization success; Rates of device-related serious adverse events		post-procedure	Yes
Secondary	modified Rankin scores		90-day	No
Secondary	mortality		90-day	Yes
Secondary	Symptomatic hemorrhage rate		24 hour post procedure	Yes

External Links

•   Concentric Medical Website