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

This study has been completed.
Sponsor:
Information provided by:
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00318071
First received: July 14, 2005
Last updated: April 15, 2008
Last verified: April 2008

July 14, 2005
April 15, 2008
January 2004
December 2006   (final data collection date for primary outcome measure)
Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
Revascularization success; Rates of procedure-related serious adverse events
Complete list of historical versions of study NCT00318071 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 30/90 day modified Rankin scores;
  • 90 day mortality;
  • symptomatic hemorrhage rate
Not Provided
Not Provided
 
Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
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)
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
Device: Merci Retriever
Experimental: Treatment
Treatment arm patients had at least one Merci Retriever deployed
Intervention: Device: Merci Retriever

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00318071
INT-LR-001
Yes
Concentric Medical
Stryker Neurovascular
Not Provided
Principal Investigator: Wade S Smith, MD, PhD University of California, San Francisco
Stryker Neurovascular
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP