Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Conditions

• Acute Ischemic Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• MT+CAS with IV-AP — PROCEDURE
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
• MT+CAS with PO-AP — PROCEDURE
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
• MT+CAT with PO-AP — PROCEDURE
  Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy

Study Details

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).

Key Dates

Start date

May 8, 2024

Status verified

Dec 2025

Primary completion

Mar 8, 2026

Completion

May 8, 2027

Study Design

Enrollment

404 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MT+CAT
  Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)
• Experimental: MT+CAS
  Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).

Primary Outcome Measure

90-day Modified Rankin Scale ordinal shift [ Time Frame: Time Frame: 90 days post randomization ]

Central Contacts

• Jasmine M Olvany, PhD
  (419)-251-4264
  [email protected]
• Laila Ibrahim, MPH
  [email protected]

Locations (51)

Find similar trials in Mobile, AL

Related Studies

• Brain, Blood And Clot or Tissue Registry And Collaboration
  Recruiting · Justin Fraser · Lexington, Kentucky
• Quelling of Excitotoxicity in Acute Stroke With Ketamine
  PHASE2/PHASE3 · Not Yet Recruiting · Lower Merion Neurology Research Foundation · Wynnewood, Pennsylvania
• A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
  PHASE2 · Recruiting · Lumosa Therapeutics Co., Ltd. · Chattanooga, Tennessee
• Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
  PHASE3 · Recruiting · Pharmazz, Inc. · Tuscon, Arizona