Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Raul Nogueira
Study ID
NCT05983757
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Experimental: endovascular thrombectomy in patients who suffer a distal medium vessel occlusion — DEVICE
    The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems, and is also indicated for use as a conduit for retrieval devices. The AXS Vecta Intermediate Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment. The Trevo® Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA).
  • Standard medical management — OTHER
    All subjects should receive the best standard medical therapy based on current AHA guidelines. Subjects randomized to standard medical management (SMM) will receive standard medical therapy only based on the guidelines. All subjects are expected to be admitted to hospital as part of routine best guideline-based care and treated on a stroke unit or neurointensive care unit or equivalent.

Study Details

A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well

Key Dates

Start date
Apr 2, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
584 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Treatment
    Standard medical management in patients who suffer a distal medium vessel occlusion
  • Experimental: Endovascular Thrombectomy
    Endovascular thrombectomy in patients who suffer a distal medium vessel occlusion.

Primary Outcome Measure

Shift in distribution of all levels of the 90-day modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment [ Time Frame: 90-day follow-up ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Grady Health SystemAtlantaGeorgia30303
Stephen Duong
[email protected]
404-251-8890
UI Health Care Medical CenterIowa CityIowa52242
Heena Olalde, MSN, RN
[email protected]
319-356-8326
ProMedicaToledoOhio43606
Kathryn Scalzo
[email protected]
419-291-4068
University of PittsburghPittsburghPennsylvania15213
Denise McCarthy, MPPM RN
[email protected]
1-878-261-6015
Nirav Bhatt, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Grady Health System· Atlanta, GAUI Health Care Medical Center· Iowa City, IAProMedica· Toledo, OHUniversity of Pittsburgh· Pittsburgh, PA

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