The Gore SCAFFOLD Clinical Study
GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy
1 other identifier
interventional
312
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedResults Posted
Study results publicly available
May 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedOctober 29, 2020
October 1, 2020
4.4 years
July 12, 2013
April 9, 2019
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
365 days
Secondary Outcomes (9)
Number of Participants Who Achieved Stent Technical Success
Procedural
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
Procedural
Number of Participants Who Achieved Procedure Success
Procedural
Number of Participants Who Experienced MAE at 30 Days
30 days
30-Day MAE - Death
30 days
- +4 more secondary outcomes
Study Arms (1)
Carotid Artery Stenting
EXPERIMENTALCarotid Artery Stenting with the GORE® Carotid Stent
Interventions
Carotid Artery Stenting with the GORE® Carotid Stent
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819, United States
Lankenau Heart Institute
Wynnewood, Pennsylvania, 19096, United States
Related Publications (1)
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.
PMID: 31713310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bryan Randall
- Organization
- W. L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
William Gray, MD
Lankenau Heart Institute
- PRINCIPAL INVESTIGATOR
Peter Schneider, MD
Kaiser Health System, Honolulu
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 17, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2017
Study Completion
September 1, 2020
Last Updated
October 29, 2020
Results First Posted
May 3, 2019
Record last verified: 2020-10