ROADSTER 3: Post-Approval Study of Transcarotid Artery Revascularization in Standard Risk Patients with Significant Carotid Artery Disease
Brief description of study
This post-approval study (PAS) evaluates real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy (a procedure to treat carotid artery disease). The study will enroll up to 400 patients at 30-60 sites in the United States.
Detailed description of study
This study will evaluate and treat participants with the transcarotid artery revascularization (TCAR) procedure. This procedure is already approved by the FDA.
The stent is an elastic-like scaffold tube made of metal/nitinol designed to help open up the narrowed carotid artery. This stent implant is permanent. The ENROUTE® Transcarotid Neuroprotection System (NPS) is a device developed to move debris away from the brain that could break off from the narrowed area of the artery during the stent implant.
Participants in the study will:
- Complete a brief interview about their medical history and any current medications
- Have a medical and neurological examination
- Have a duplex Doppler ultrasound and/or an angiogram
- Undergo a computed tomography angiography (CTA) or magnetic resonance angiography (MRA) to visualize the blood vessels in their head and neck (if necessary).
- Have three follow-up visits at the study site after the procedure
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Carotid Artery Disease
-
Age: Between 18 Years - 79 Years
-
Gender: All
Inclusion
- ≥ 18 and < 80 years of age
- Have a discrete lesion located in the internal carotid artery (ICA)
- Must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
1. Symptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥50% stenosis of the common or internal carotid artery by angiogram
OR
2. Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥60% stenosis of the common or internal carotid artery by angiogram
OR
2. Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥60% stenosis of the common or internal carotid artery by angiogram
- Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System
Exclusion
- Hemorrhagic transformation of an ischemic stroke within the past 60 days
- Has an intracranial tumor
- History of major stroke prior to the TCAR procedure attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit
- Diagnosed with neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke
Updated on
09 Mar 2024.
Study ID: 2022-46
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu
For cancer trials contact EmergingMed: 1-855-216-0098 or PennCancerTrials@emergingmend.com
