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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00318071
First received: July 14, 2005
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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)

Condition Intervention
Ischemic Stroke
Device: Merci Retriever

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • modified Rankin scores [ Time Frame: 90-day ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]
  • Symptomatic hemorrhage rate [ Time Frame: 24 hour post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 164
Study Start Date: January 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment arm patients had at least one Merci Retriever deployed
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.


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318071

Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Wade S Smith, MD, PhD University of California, San Francisco
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00318071     History of Changes
Other Study ID Numbers: INT-LR-001
Study First Received: July 14, 2005
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy
Merci
Concentric
Embolus
Embolism
Mechanical

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014