Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial

NCT01657461 | Completed Results DMC

• 1 other identifier: NV-SFR004
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).

  mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

  90 days

Secondary Outcomes (7)

• Death Due to Any Cause at 90 Days

  90 days

• Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days

  90 days

• Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization

  Baseline to 27±6 hours post randomization

• Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization

  27±6 hours post randomization

• Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization

  27±6 hours post randomization

Other Outcomes (2)

• Incidence of All Serious Adverse Events (SAEs)

  Through 90 days

• Incidence of sICH at 27±6 Hours Post Randomization

  27±6 hours post randomization

Study Arms (2)

IV t-PA with Solitaire™ revascularization device

EXPERIMENTAL

Dual IV tPA therapy and adjunctive treatment with the Solitaire revascularization device

Device: Solitaire revascularization device

IV t-PA

ACTIVE COMPARATOR

Infusion of intravenous tissue plasminogen activator (IV t-PA)

Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

Interventions

Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) DRUG

Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

IV t-PA

Solitaire revascularization device DEVICE

Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator

IV t-PA with Solitaire™ revascularization device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80
• Clinical signs consistent with acute ischemic stroke
• Prestroke Modified Rankin Score ≤ 1
• NIHSS ≥ 8 and \< 30 at the time of randomization
• Initiation of IV t-PA within 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received / is receiving the correct IV t-PA dose for the estimated weight prior to randomization.
• Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in the intracranial internal carotid artery, M1 segment of the MCA, or carotid terminus confirmed by CT or MR angiography that is accessible to the Solitaire™ FR Device.
• Subject is able to be treated within 6 hours of onset of stroke symptoms and within 1.5 hours (90 minutes) from CTA or MRA to groin puncture.
• Subject is willing to conduct protocol-required follow-up visits.
• An appropriate signed and dated Informed Consent Form (as allowed according to country regulations and approved by ethics committee and/or IRB) has been obtained
• Subject is affiliated with a social security system (if required by individual country regulations).
• Subject meets national regulatory criteria for clinical trial participation.

You may not qualify if:

• Subject who is contraindicated to IV t-PA as per local national guidelines.
• Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
• As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person.
• Rapid neurological improvement prior to study randomization suggesting resolution of signs/symptoms of stroke.
• Known serious sensitivity to radiographic contrast agents.
• Known sensitivity to Nickel, Titanium metals or their alloys.
• Current participation in another investigational drug or device treatment study.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrollment.)
• Renal Failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate \[GFR\] \< 30Warfarin therapy with INR greater than 1.7.
• Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
• Life expectancy of less than 90 days.
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
• Suspicion of aortic dissection.
• Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
• Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead

Study Sites (1)

Kaleida Health/Buffalo General

Buffalo, New York, 14203, United States

Location

Related Publications (10)

• Raychev R, Saver JL, Jahan R, Nogueira RG, Goyal M, Pereira VM, Gralla J, Levy EI, Yavagal DR, Cognard C, Liebeskind DS. The impact of general anesthesia, baseline ASPECTS, time to treatment, and IV tPA on intracranial hemorrhage after neurothrombectomy: pooled analysis of the SWIFT PRIME, SWIFT, and STAR trials. J Neurointerv Surg. 2020 Jan;12(1):2-6. doi: 10.1136/neurintsurg-2019-014898. Epub 2019 Jun 25.

  PMID: 31239326 DERIVED

• Eker OF, Saver JL, Goyal M, Jahan R, Levy EI, Nogueira RG, Yavagal DR, Bonafe A; SWIFT PRIME investigators. Impact of Anesthetic Management on Safety and Outcomes Following Mechanical Thrombectomy for Ischemic Stroke in SWIFT PRIME Cohort. Front Neurol. 2018 Aug 29;9:702. doi: 10.3389/fneur.2018.00702. eCollection 2018.

  PMID: 30210431 DERIVED

• 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

• Arenillas JF, Cortijo E, Garcia-Bermejo P, Levy EI, Jahan R, Liebeskind D, Goyal M, Saver JL, Albers GW. Relative cerebral blood volume is associated with collateral status and infarct growth in stroke patients in SWIFT PRIME. J Cereb Blood Flow Metab. 2018 Oct;38(10):1839-1847. doi: 10.1177/0271678X17740293. Epub 2017 Nov 14.

  PMID: 29135347 DERIVED

• Raychev R, Jahan R, Saver JL, Nogueira RG, Goyal M, Pereira VM, Levy E, Yavagal DR, Cognard C, Liebeskind D. Microcatheter contrast injection in stent retriever neurothrombectomy is safe and useful: insights from SWIFT PRIME. J Neurointerv Surg. 2018 Jul;10(7):615-619. doi: 10.1136/neurintsurg-2017-013397. Epub 2017 Nov 10.

  PMID: 29127195 DERIVED

• Menjot de Champfleur N, Saver JL, Goyal M, Jahan R, Diener HC, Bonafe A, Levy EI, Pereira VM, Cognard C, Yavagal DR, Albers GW. Efficacy of Stent-Retriever Thrombectomy in Magnetic Resonance Imaging Versus Computed Tomographic Perfusion-Selected Patients in SWIFT PRIME Trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke). Stroke. 2017 Jun;48(6):1560-1566. doi: 10.1161/STROKEAHA.117.016669. Epub 2017 May 2.

  PMID: 28465460 DERIVED

• Mokin M, Levy EI, Saver JL, Siddiqui AH, Goyal M, Bonafe A, Cognard C, Jahan R, Albers GW; SWIFT PRIME Investigators. Predictive Value of RAPID Assessed Perfusion Thresholds on Final Infarct Volume in SWIFT PRIME (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment). Stroke. 2017 Apr;48(4):932-938. doi: 10.1161/STROKEAHA.116.015472. Epub 2017 Mar 10.

  PMID: 28283606 DERIVED

• Shireman TI, Wang K, Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Jahan R, Vilain KA, House J, Lee JM, Cohen DJ; SWIFT-PRIME Investigators. Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results From the SWIFT-PRIME Trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke). Stroke. 2017 Feb;48(2):379-387. doi: 10.1161/STROKEAHA.116.014735. Epub 2016 Dec 27.

  PMID: 28028150 DERIVED

• Albers GW, Goyal M, Jahan R, Bonafe A, Diener HC, Levy EI, Pereira VM, Cognard C, Yavagal DR, Saver JL. Relationships Between Imaging Assessments and Outcomes in Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke. Stroke. 2015 Oct;46(10):2786-94. doi: 10.1161/STROKEAHA.115.010710. Epub 2015 Aug 27.

  PMID: 26316344 DERIVED

• Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.

  PMID: 25882376 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Manish Gupta, Sr. Director of Medical Affairs
• Organization: Medtronic

manish.s.gupta@medtronic.com

949 297 5494

Study Officials

• Jeffrey Saver, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 18, 2017
• Results First Posted: May 18, 2017

Record last verified: 2017-04

Locations

US (1)