| 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
|
| |
| 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)
|
| |
| |
| Interventional |
| Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Ischemic Stroke |
| Device: Merci Retriever |
| Experimental: Treatment arm patients had at least one Merci Retriever deployed |
- 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. Epub 2008 Feb 28.
- 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.
- 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. Epub 2007 Mar 1.
- 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.
|
| |
| 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 |
|
| |
| NCT00318071 |
| Concentric Medical |
| INT-LR-001 |
| Concentric Medical |
|
| Principal Investigator: |
Wade S Smith, MD, PhD |
University of California, San Francisco |
|
|
| Concentric Medical |
| April 2008 |