Clinical trial NCT01901874: The Gore SCAFFOLD Clinical Study
Official title: GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Carotid Artery Stenosis
Keywords: Stroke
Carotid Artery Stenting (CAS)
Embolic Protection Device (EPD)
Stent
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Angioplasty
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy

Detailed description: This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old at informed consent
* Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.
* Patient is willing to provide written informed consent prior to enrollment in study.
* Patient is either:

  * Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR
  * Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology
* Patient must be considered high risk for adverse events during carotid endarterectomy

Note: Additional inclusion criteria may apply

Exclusion Criteria:

* Patient has life expectancy of less than one year.
* Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke.
* Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months).
* Patient has had an acute myocardial infarction within 72 hours prior to the index procedure.
* Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments.
* Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure.

Note: Additional exclusion criteria may apply

Primary outcomes:
measure: Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
timeFrame: 365 days
Secondary outcomes:
measure: Number of Participants Who Achieved Stent Technical Success
timeFrame: Procedural
measure: Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
timeFrame: Procedural
measure: Number of Participants Who Achieved Procedure Success
timeFrame: Procedural
measure: Number of Participants Who Experienced MAE at 30 Days
timeFrame: 30 days
measure: 30-Day MAE - Death
timeFrame: 30 days
measure: 30-Day MAE - Myocardial Infarction
timeFrame: 30 days
measure: 30-Day MAE - Stroke
timeFrame: 30 days
measure: In-Stent Restenosis
timeFrame: 365 days
measure: Target Lesion Revascularization
timeFrame: 365 days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Wynnewood
country: United States
facility: Lankenau Heart Institute
state: Pennsylvania
Study officials:
affiliation: Lankenau Heart Institute
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Health System, Honolulu
name: Peter Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gray WA, Levy E, Bacharach JM, Metzger DC, Randall B, Siddiqui A, Schonholz C, Alani F, Schneider PA. Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial. Catheter Cardiovasc Interv. 2020 Jul;96(1):121-127. doi: 10.1002/ccd.28586. Epub 2019 Nov 11.