MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia

Y. Pierre Gobin, Sidney Starkman, Gary R. Duckwiler, Thomas Grobelny, Stella Kidwell, Reza Jahan, John Pile-Spellman, Alan Segal, Fernando Vinuela, Jeffrey L. Saver

Research output: Contribution to journalArticle

366 Citations (Scopus)

Abstract

Background and Purpose - To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature. Methods - MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) ≥10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy. Results - Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43%) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64%) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery. Conclusion - This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.

Original languageEnglish (US)
Pages (from-to)2848-2853
Number of pages6
JournalStroke
Volume35
Issue number12
DOIs
StatePublished - Dec 2004
Externally publishedYes

Fingerprint

Embolism
Brain Ischemia
Embolectomy
National Institutes of Health (U.S.)
Stroke
Intracranial Hemorrhages
Safety
Cerebral Arteries
Vascular System Injuries
Tissue Plasminogen Activator
Angiography
Tomography
Therapeutics

Keywords

  • Embolectomy
  • Stroke, ischemic
  • Thrombectomy
  • Thrombolytic therapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Gobin, Y. P., Starkman, S., Duckwiler, G. R., Grobelny, T., Kidwell, S., Jahan, R., ... Saver, J. L. (2004). MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia. Stroke, 35(12), 2848-2853. https://doi.org/10.1161/01.STR.0000147718.12954.60

MERCI 1 : A phase 1 study of mechanical embolus removal in cerebral ischemia. / Gobin, Y. Pierre; Starkman, Sidney; Duckwiler, Gary R.; Grobelny, Thomas; Kidwell, Stella; Jahan, Reza; Pile-Spellman, John; Segal, Alan; Vinuela, Fernando; Saver, Jeffrey L.

In: Stroke, Vol. 35, No. 12, 12.2004, p. 2848-2853.

Research output: Contribution to journalArticle

Gobin, YP, Starkman, S, Duckwiler, GR, Grobelny, T, Kidwell, S, Jahan, R, Pile-Spellman, J, Segal, A, Vinuela, F & Saver, JL 2004, 'MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia', Stroke, vol. 35, no. 12, pp. 2848-2853. https://doi.org/10.1161/01.STR.0000147718.12954.60
Gobin, Y. Pierre ; Starkman, Sidney ; Duckwiler, Gary R. ; Grobelny, Thomas ; Kidwell, Stella ; Jahan, Reza ; Pile-Spellman, John ; Segal, Alan ; Vinuela, Fernando ; Saver, Jeffrey L. / MERCI 1 : A phase 1 study of mechanical embolus removal in cerebral ischemia. In: Stroke. 2004 ; Vol. 35, No. 12. pp. 2848-2853.
@article{1d01f5757f3048f08a8665a4cf91ca8f,
title = "MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia",
abstract = "Background and Purpose - To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature. Methods - MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) ≥10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy. Results - Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43{\%}) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64{\%}) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery. Conclusion - This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.",
keywords = "Embolectomy, Stroke, ischemic, Thrombectomy, Thrombolytic therapy",
author = "Gobin, {Y. Pierre} and Sidney Starkman and Duckwiler, {Gary R.} and Thomas Grobelny and Stella Kidwell and Reza Jahan and John Pile-Spellman and Alan Segal and Fernando Vinuela and Saver, {Jeffrey L.}",
year = "2004",
month = "12",
doi = "10.1161/01.STR.0000147718.12954.60",
language = "English (US)",
volume = "35",
pages = "2848--2853",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "12",

}

TY - JOUR

T1 - MERCI 1

T2 - A phase 1 study of mechanical embolus removal in cerebral ischemia

AU - Gobin, Y. Pierre

AU - Starkman, Sidney

AU - Duckwiler, Gary R.

AU - Grobelny, Thomas

AU - Kidwell, Stella

AU - Jahan, Reza

AU - Pile-Spellman, John

AU - Segal, Alan

AU - Vinuela, Fernando

AU - Saver, Jeffrey L.

PY - 2004/12

Y1 - 2004/12

N2 - Background and Purpose - To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature. Methods - MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) ≥10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy. Results - Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43%) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64%) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery. Conclusion - This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.

AB - Background and Purpose - To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature. Methods - MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) ≥10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy. Results - Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43%) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64%) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery. Conclusion - This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.

KW - Embolectomy

KW - Stroke, ischemic

KW - Thrombectomy

KW - Thrombolytic therapy

UR - http://www.scopus.com/inward/record.url?scp=20844445437&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20844445437&partnerID=8YFLogxK

U2 - 10.1161/01.STR.0000147718.12954.60

DO - 10.1161/01.STR.0000147718.12954.60

M3 - Article

C2 - 15514171

AN - SCOPUS:20844445437

VL - 35

SP - 2848

EP - 2853

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 12

ER -