Acute StrokePhase 3REVASCATNCT01692379
Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours
A Phase 3 study testing Solitaire FR device and Medical treatment in people with Acute Stroke, run by Fundacio Ictus Malaltia Vascular at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Solitaire FR device and Medical treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 4 sitesSpain
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 23Show fewer
- 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).
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario Vall D'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic
Barcelona, Barcelona, 08036
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
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
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.
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- Solitaire FR device, Medical treatment
- Keywords
- Acute ischemic stroke, endovascular treatment, clinical trial
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solitaire FR deviceDevice
Mechanical embolectomy in anterior large vessel occlusion
Medical treatmentOther
Standard of care in acute ischemic stroke including intravenous rTPA
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Experimental | Mechanical embolectomy with Solitaire FR device Receives: Device: Solitaire FR device |
| Medical treatment | Active comparator | Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)
evaluated by two separate assessors who are blinded to treatment
Measured: 90 days after enrollment
Secondary outcomes (5)
Mortality at 90 days
Measured: 90 days after enrollment
Symptomatic Intracerebral Hemorrhage
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
Measured: 24h (-2/+12 hours) after enrollment
Infarct Volume
Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab
Measured: 24h (-2/+12h) post treatment
Vessel recanalization
Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab
Measured: 24h post treatment
Intraprocedural related complications in endovascular arm
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
Measured: During endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionDec 2015
Why it stopped: Following DSMB advice after first interim analysis (n=174)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Ictus Malaltia Vascular
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Antoni Dávalos, MD, Study chair, Hospital Universitario Germans Trias i Pujol, Barcelona, SpainTudor Jovin, MD, Study chair, UPMC Stroke Institute, Pittsburgh, PA, USAAngel Chamorro, MD, Study director, Hospital Clinic Barcelona, Barcelona, SpainJoaquin Serena, MD, Study director, Hospital Josep Trueta, Girona, SpainAlex Rovira, MD, Study director, Hospital Vall D'Hebron, Barcelona, SpainMaria A De Miquel, MD, Study director, Hospital de Bellvitge, Barcelona, SpainLuis Sanromán, MD, Study director, Hospital Clinic, Barcelona, SpainErik Cobo, MD, Study director, UPC, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692379
- Sponsor's protocol ID
- REVASCAT
- Acronym
- REVASCAT
- Status last verified
- Feb 2016
- First submitted
- 20 Sep 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24206399Kaneko 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.
PubMed 30045949Al-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.
PubMed 29170266Davalos 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.
PubMed 28318984Millan 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.
PubMed 28292867Lopez-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.
PubMed 27940648Ribo 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.
PubMed 26956258Lopez-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.
PubMed 26542697Urra 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.
PubMed 26508752Jovin 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.
PubMed 25882510Abilleira 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.
PubMed 25428822
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01692379
- Acronym / sponsor ID
- REVASCAT / REVASCAT
- Conditions
- Acute Stroke
- Keywords
- Acute ischemic stroke, endovascular treatment, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following DSMB advice after first interim analysis (n=174)
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Fundacio Ictus Malaltia VascularUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | Experimental | Device: Solitaire FR deviceMechanical embolectomy with Solitaire FR device |
| Medical treatment | Active comparator | Other: Medical treatmentMedical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solitaire FR deviceMechanical embolectomy in anterior large vessel occlusion | Device | Endovascular treatment |
| Medical treatmentStandard of care in acute ischemic stroke including intravenous rTPA | Other | Medical treatment |
Primary outcome
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
5 secondary outcomes
Mortality at 90 days
Time frame: 90 days after enrollment
Symptomatic Intracerebral Hemorrhage
Time frame: 24h (-2/+12 hours) after enrollment
Infarct Volume
Time frame: 24h (-2/+12h) post treatment
Vessel recanalization
Time frame: 24h post treatment
Intraprocedural related complications in endovascular arm
Time frame: During endovascular treatment
Results and safety
The study was stopped early (reason given: Following DSMB advice after first interim analysis (n=174)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 24206399Molina 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.
- Derived from this study: PubMed 30045949Kaneko 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.
- Derived from this study: PubMed 29170266Al-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.
- Derived from this study: PubMed 28318984Davalos 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.
- Derived from this study: PubMed 28292867Millan 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.
- Derived from this study: PubMed 27940648Lopez-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.
- Derived from this study: PubMed 26956258Ribo 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.
- Derived from this study: PubMed 26542697Lopez-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.
- Derived from this study: PubMed 26508752Urra 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.
- Derived from this study: PubMed 25882510Jovin 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.
- Derived from this study: PubMed 25428822Abilleira 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.
- Fundacio Ictus is a non-profit organization sponsoring REVASCAT studyLink provided by the sponsor.
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Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Dávalos, MD study chair
Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
Tudor Jovin, MD study chair
UPMC Stroke Institute, Pittsburgh, PA, USA
Angel Chamorro, MD study director
Hospital Clinic Barcelona, Barcelona, Spain
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solitaire FR device and Medical treatment in people with Acute Stroke, run by Fundacio Ictus Malaltia Vascular at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following DSMB advice after first interim analysis (n=174)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) (time frame: 90 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692379, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.