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

February 2, 2016 updated by: Fundacio Ictus Malaltia Vascular

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias I Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 ≤ 85.
  • 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 NCCT or <6 on DWI MRI. Patients 81 to 85 years old with ASPECTS score on non-contrast CT or DWI MRI <9 must be excluded. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)
Time Frame: 90 days after enrollment
evaluated by two separate assessors who are blinded to treatment
90 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 90 days
Time Frame: 90 days after enrollment
90 days after enrollment
Symptomatic Intracerebral Hemorrhage
Time Frame: 24h (-2/+12 hours) after enrollment
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
24h (-2/+12 hours) after enrollment
Infarct Volume
Time Frame: 24h (-2/+12h) post treatment
Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab
24h (-2/+12h) post treatment
Vessel recanalization
Time Frame: 24h post treatment
Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab
24h post treatment
Intraprocedural related complications in endovascular arm
Time Frame: During endovascular treatment
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
During endovascular treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Ictus Malaltia Vascular

Collaborators

Medtronic - MITG

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'HEBRÓN, 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'HEBRÓN, Barcelona, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REVASCAT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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