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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Fundacio Ictus Malaltia Vascular
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Fundacio Ictus Malaltia Vascular
ClinicalTrials.gov Identifier:
NCT01692379
First received: September 20, 2012
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Acute Stroke
Device: Solitaire FR device
Other: Medical treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 8 Hours of Symptom Onset

Resource links provided by NLM:


Further study details as provided by Fundacio Ictus Malaltia Vascular:

Primary Outcome Measures:
  • Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) [ Time Frame: 90 days after enrollment ] [ Designated as safety issue: No ]
    evaluated by two separate assessors who are blinded to treatment


Secondary Outcome Measures:
  • Mortality at 90 days [ Time Frame: 90 days after enrollment ] [ Designated as safety issue: Yes ]
  • Symptomatic Intracerebral Hemorrhage [ Time Frame: 24h (-2/+12 hours) after enrollment ] [ Designated as safety issue: Yes ]
    Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans evaluated by independent CT/MR Core Lab and Clinical Events Committee

  • Infarct Volume [ Time Frame: 24h (-2/+12h) post treatment ] [ Designated as safety issue: No ]
    Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab

  • Vessel recanalization [ Time Frame: 24h post treatment ] [ Designated as safety issue: No ]
    Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab

  • Intraprocedural related complications in endovascular arm [ Time Frame: During endovascular treatment ] [ Designated as safety issue: Yes ]
    Procedural related complications in the endovascular treatment arm: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory evaluated by the Angiography Core Lab and the Clinical Events Committee


Estimated Enrollment: 690
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular treatment
Mechanical embolectomy with Solitaire FR device
Device: Solitaire FR device
Mechanical embolectomy in anterior large vessel occlusion
Active Comparator: Medical treatment
Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis
Other: Medical treatment
Standard of care in acute ischemic stroke including intravenous rTPA

Detailed Description:

Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical embolectomy with the CE MARK approved stentriever Solitaire FR® versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, therapeutic window and vessel occlusion site. For the primary endpoint, subjects will be followed for 90 days post-randomization.

Interim analysis will be performed as preplanned and interpreted by the Data Safety Monitoring Board (DSMB) after the first 174, 346 and 518 patients representing 25%, 50% and 75% of the planned sample size have completed their 90-day follow-up. The DSMB will advise the executive committee (EC) on recommendations to stop the trial early either for reasons of safety, efficacy, futility or to adjust the sample size. The latter may be necessary as given the paucity of data regarding natural history of the non-treated patients assumptions regarding rates of favorable outcomes in this group of patients may be incorrect. Of note, sample size adjustment based on different than expected outcomes rates is permitted, but it is not permitted to adjust the sample size based on change in the pre-specified treatment effect which is set at 10%.

Subject population: Subjects presenting with acute ischemic stroke within 8 hours from symptom onset and whose strokes are attributable to an occlusion of the internal carotid or proximal MCA (M1) arteries. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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
  • 2. No significant pre-stroke functional disability (mRS ≤ 1)
  • 3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points
  • 4. Age ≥18 and < 80
  • 5. 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
  • 6. 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.
  • 7. Informed consent obtained from patient or acceptable patient surrogate

Exclusion Criteria:

  • Clinical criteria
  • 1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
  • 2. Baseline platelet count < 30.000/µL
  • 3. Baseline blood glucose of < 50mg/dL or >400mg/dl
  • 4. Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg)
  • 5. 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).
  • 6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS
  • 7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
  • 8. History of life threatening allergy (more than rash) to contrast medium
  • 9. Subjects who has received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
  • 10. Renal insufficiency with creatinine ≥ 3 mg/dl
  • 11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
  • 12. Subject participating in a study involving an investigational drug or device that would impact this study.
  • 13. Cerebral vasculitis
  • 14. 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.)
  • 15. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).

Neuroimaging criteria:

  • 16. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on CT, CTP-CBV, CTA-SI or <6 on DWI MRI. ASPECTS must be evaluated by CBV maps of CT Perfusion, CTA source imaging (CTA-SI) or DWI-MR in patients whose vascular occlusion study (CTA/MRA) confirming qualifying occlusion, is performed beyond 4.5 hours of last seen well.
  • 17. CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).
  • 18. Significant mass effect with midline shift.
  • 19. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
  • 20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
  • 21. Evidence of intracranial tumor (except small meningioma).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692379

Contacts
Contact: Antoni Dávalos, MD 00 34 934978916 adavalos.germanstrias@gencat.cat
Contact: Tudor Jovin, MD 00 1 412-6473030 jovintg@upmc.edu

Locations
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Mónica Millán, MD    0034 934978733    mmillan.germanstrias@gencat.cat   
Contact: Elena López-Cancio, MD    0034 934978911    elenacancio@gmail.com   
Principal Investigator: Monica Millán, MD         
Hospital Universitari Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Pere Cardona, MD       pcardonap@bellvitgehospital.cat   
Principal Investigator: Pere Cardona, MD         
Hospital Universitario Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Marc Ribo, MD    0034 93 4893000    marcriboj@hotmail.com   
Principal Investigator: Marc Ribo, MD         
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Angel Chamorro, MD    0034 93227 5414    achamorro@ub.edu   
Principal Investigator: Angel Chamorro, MD         
Sponsors and Collaborators
Fundacio Ictus Malaltia Vascular
Covidien
Investigators
Study Chair: Antoni Dávalos, MD Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
Study Chair: Tudor Jovin, MD UPMC Stroke Institute, Pittsburgh, PA, USA
Study Director: 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
  More Information

Additional Information:
Publications:
Responsible Party: Fundacio Ictus Malaltia Vascular
ClinicalTrials.gov Identifier: NCT01692379     History of Changes
Other Study ID Numbers: REVASCAT
Study First Received: September 20, 2012
Last Updated: December 1, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundacio Ictus Malaltia Vascular:
Acute ischemic stroke
endovascular treatment
clinical trial

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014