Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
This study has been completed.
Sponsor:
Concentric Medical
Information provided by:
Concentric Medical
ClinicalTrials.gov Identifier:
NCT00318071
First received: July 14, 2005
Last updated: April 15, 2008
Last verified: April 2008
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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: | Allocation: Non-Randomized 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 Concentric Medical:
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 |
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 More Information
Additional Information:
Publications:
| Responsible Party: | Concentric Medical |
| ClinicalTrials.gov Identifier: | NCT00318071 History of Changes |
| Other Study ID Numbers: | INT-LR-001 |
| Study First Received: | July 14, 2005 |
| Last Updated: | April 15, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Concentric Medical:
|
Stroke Ischemic Thrombus Embolectomy Thrombectomy |
Merci Concentric Embolus Embolism Mechanical |
Additional relevant MeSH terms:
|
Cerebral Infarction Brain Ischemia Ischemia Stroke Brain Infarction Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013