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New treatment option for Acute Ischemic Stroke
Official title Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
ClinicalTrials.gov ID: NCT05611242
What this study is testing
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 18 to 79 years of age (before the 80th birthday)
- Presenting with symptoms consistent with AIS
- Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1)...
- NIHSS ≥ 4
- Ability to randomize and start endovascular therapy within 16 hours of stroke onset
You likely can't join if
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication
- CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
See the full eligibility criteria
- 18 to 79 years of age (before the 80th birthday)
- Presenting with symptoms consistent with AIS
- Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion /...
- NIHSS ≥ 4
- Ability to randomize and start endovascular therapy within 16 hours of stroke onset
- Pre-stroke mRS score 0-2
- Ability to obtain signed informed consent
- ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for people ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume \ 6h to 16 hours from stroke onset, given the need for antiplatelet therapy.
- Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
- Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication
- CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
- Acute bilateral strokes
- Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
- Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7 or Partial Thromboplastin Time (PTT) \> 3 times of normal
- Baseline platelet count \<100,000 per microliter (μl)
- Life expectancy less than one year prior to stroke onset
- Participation in another assigned by chance clinical trial that could confound the evaluation of the study outcomes
- Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
- Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Glendale, California, United States
- Irvine, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Boca Raton, Florida, United States
- Delray Beach, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Winfield, Illinois, United States
- Indianapolis, Indiana, United States
- Munster, Indiana, United States
- Kansas City, Kansas, United States
+ 29 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Glendale, California, United States; Irvine, California, United States; Pomona, California, United States; Sacramento, California, United States; San Francisco, California, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.