Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours

NCT01692379 | Terminated Phase 3 DMC

• 1 other identifier: REVASCAT
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.

Conditions

Acute Stroke

Keywords

Acute ischemic stroke; endovascular treatment; clinical trial

Outcome Measures

Primary Outcomes (1)

• Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)

  evaluated by two separate assessors who are blinded to treatment

  90 days after enrollment

Secondary Outcomes (5)

• Mortality at 90 days

  90 days after enrollment

• Symptomatic Intracerebral Hemorrhage

  24h (-2/+12 hours) after enrollment

• Infarct Volume

  24h (-2/+12h) post treatment

• Vessel recanalization

  24h post treatment

• Intraprocedural related complications in endovascular arm

  During endovascular treatment

Study Arms (2)

Endovascular treatment

EXPERIMENTAL

Mechanical embolectomy with Solitaire FR device

Device: Solitaire FR device

Medical treatment

ACTIVE COMPARATOR

Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis

Other: Medical treatment

Interventions

Solitaire FR device DEVICE

Mechanical embolectomy in anterior large vessel occlusion

Endovascular treatment

Medical treatment OTHER

Standard of care in acute ischemic stroke including intravenous rTPA

Medical treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization after a minimum of 30 min from start of iv tPA infusion
• \. No significant pre-stroke functional disability (mRS ≤ 1)
• \. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points
• \. Age ≥18 and ≤ 85.
• \. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA-M1 segment or tandem proximal ICA/MCA-M1 suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis
• \. Patient treatable within eight hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as groin puncture.
• \. Informed consent obtained from patient or acceptable patient surrogate

You may not qualify if:

• Clinical criteria
• \. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
• \. Baseline platelet count \< 30.000/µL
• \. Baseline blood glucose of \< 50mg/dL or \>400mg/dl
• \. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg)
• \. Patients in coma (NIHSS item of consciousness \>1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
• \. Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• \. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• \. History of life threatening allergy (more than rash) to contrast medium
• \. Subjects who has received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
• \. Renal insufficiency with creatinine ≥ 3 mg/dl
• \. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• \. Subject participating in a study involving an investigational drug or device that would impact this study.
• \. Cerebral vasculitis
• \. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤ 1. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)

Sponsors & Collaborators

• Fundacio Ictus Malaltia Vascular: lead
• Medtronic - MITG: collaborator

Study Sites (4)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (11)

• Molina CA, Chamorro A, Rovira A, de Miquel A, Serena J, Roman LS, Jovin TG, Davalos A, Cobo E. REVASCAT: a randomized trial of revascularization with SOLITAIRE FR device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset. Int J Stroke. 2015 Jun;10(4):619-26. doi: 10.1111/ijs.12157. Epub 2013 Nov 10.

  PMID: 24206399 BACKGROUND

• Kaneko N, Komuro Y, Yokota H, Tateshima S. Stent retrievers with segmented design improve the efficacy of thrombectomy in tortuous vessels. J Neurointerv Surg. 2019 Feb;11(2):119-122. doi: 10.1136/neurintsurg-2018-014061. Epub 2018 Jul 24.

  PMID: 30045949 DERIVED

• Al-Ajlan FS, Al Sultan AS, Minhas P, Assis Z, de Miquel MA, Millan M, San Roman L, Tomassello A, Demchuk AM, Jovin TG, Cuadras P, Davalos A, Goyal M, Menon BK; REVASCAT Investigators. Posttreatment Infarct Volumes when Compared with 24-Hour and 90-Day Clinical Outcomes: Insights from the REVASCAT Randomized Controlled Trial. AJNR Am J Neuroradiol. 2018 Jan;39(1):107-110. doi: 10.3174/ajnr.A5463. Epub 2017 Nov 23.

  PMID: 29170266 DERIVED

• Davalos A, Cobo E, Molina CA, Chamorro A, de Miquel MA, Roman LS, Serena J, Lopez-Cancio E, Ribo M, Millan M, Urra X, Cardona P, Tomasello A, Castano C, Blasco J, Aja L, Rubiera M, Gomis M, Renu A, Lara B, Marti-Fabregas J, Jankowitz B, Cerda N, Jovin TG; REVASCAT Trial Investigators. Safety and efficacy of thrombectomy in acute ischaemic stroke (REVASCAT): 1-year follow-up of a randomised open-label trial. Lancet Neurol. 2017 May;16(5):369-376. doi: 10.1016/S1474-4422(17)30047-9. Epub 2017 Mar 16.

  PMID: 28318984 DERIVED

• Millan M, Remollo S, Quesada H, Renu A, Tomasello A, Minhas P, Perez de la Ossa N, Rubiera M, Llull L, Cardona P, Al-Ajlan F, Hernandez M, Assis Z, Demchuk AM, Jovin T, Davalos A; REVASCAT Trial Investigators. Vessel Patency at 24 Hours and Its Relationship With Clinical Outcomes and Infarct Volume in REVASCAT Trial (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset). Stroke. 2017 Apr;48(4):983-989. doi: 10.1161/STROKEAHA.116.015455. Epub 2017 Mar 14.

  PMID: 28292867 DERIVED

• Lopez-Cancio E, Jovin TG, Cobo E, Cerda N, Jimenez M, Gomis M, Hernandez-Perez M, Caceres C, Cardona P, Lara B, Renu A, Llull L, Boned S, Muchada M, Davalos A. Endovascular treatment improves cognition after stroke: A secondary analysis of REVASCAT trial. Neurology. 2017 Jan 17;88(3):245-251. doi: 10.1212/WNL.0000000000003517. Epub 2016 Dec 9.

  PMID: 27940648 DERIVED

• Ribo M, Molina CA, Cobo E, Cerda N, Tomasello A, Quesada H, De Miquel MA, Millan M, Castano C, Urra X, Sanroman L, Davalos A, Jovin T; REVASCAT Trial Investigators. Association Between Time to Reperfusion and Outcome Is Primarily Driven by the Time From Imaging to Reperfusion. Stroke. 2016 Apr;47(4):999-1004. doi: 10.1161/STROKEAHA.115.011721. Epub 2016 Mar 8.

  PMID: 26956258 DERIVED

• Lopez-Cancio E, Salvat M, Cerda N, Jimenez M, Codas J, Llull L, Boned S, Cano LM, Lara B, Molina C, Cobo E, Davalos A, Jovin TG, Serena J; REVASCAT investigators. Phone and Video-Based Modalities of Central Blinded Adjudication of Modified Rankin Scores in an Endovascular Stroke Trial. Stroke. 2015 Dec;46(12):3405-10. doi: 10.1161/STROKEAHA.115.010909. Epub 2015 Nov 5.

  PMID: 26542697 DERIVED

• Urra X, Abilleira S, Dorado L, Ribo M, Cardona P, Millan M, Chamorro A, Molina C, Cobo E, Davalos A, Jovin TG, Gallofre M; Catalan Stroke Code and Reperfusion Consortium. Mechanical Thrombectomy in and Outside the REVASCAT Trial: Insights From a Concurrent Population-Based Stroke Registry. Stroke. 2015 Dec;46(12):3437-42. doi: 10.1161/STROKEAHA.115.011050. Epub 2015 Oct 27.

  PMID: 26508752 DERIVED

• Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

  PMID: 25882510 DERIVED

• Abilleira S, Ribera A, Davalos A, Ribo M, Chamorro A, Cardona P, Molina CA, Martinez-Yelamos A, Urra X, Dorado L, Roquer J, Marti-Fabregas J, Aja L, Tomasello A, Castano C, Blasco J, Canovas D, Castellanos M, Krupinski J, Guimaraens L, Perendreu J, Ustrell X, Purroy F, Gomez-Choco M, Baiges JJ, Cocho D, Saura J, Gallofre M; Catalan Stroke Code and Reperfusion Consortium. Functional outcome after primary endovascular therapy or IV thrombolysis alone for stroke. An observational, comparative effectiveness study. Cerebrovasc Dis. 2014;38(5):328-36. doi: 10.1159/000368433. Epub 2014 Nov 21.

  PMID: 25428822 DERIVED

Related Links

• Fundacio Ictus is a non-profit organization sponsoring REVASCAT study

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antoni Dávalos, MD

  Hospital Universitario Germans Trias i Pujol, Barcelona, Spain

  STUDY CHAIR

• Tudor Jovin, MD

  UPMC Stroke Institute, Pittsburgh, PA, USA

  STUDY CHAIR

• Angel Chamorro, MD

  Hospital Clinic Barcelona, Barcelona, Spain

  STUDY DIRECTOR

• Joaquin Serena, MD

  Hospital Josep Trueta, Girona, Spain

  STUDY DIRECTOR

• Alex Rovira, MD

  Hospital Vall D'Hebron, Barcelona, Spain

  STUDY DIRECTOR

• Maria A De Miquel, MD

  Hospital de Bellvitge, Barcelona, Spain

  STUDY DIRECTOR

• Luis Sanromán, MD

  Hospital Clinic, Barcelona, Spain

  STUDY DIRECTOR

• Erik Cobo, MD

  UPC, Barcelona, Spain

  STUDY DIRECTOR

• Carlos Molina, MD

  Hospital Vall D'Hebron, Barcelona, Spain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 25, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

ES (4)