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

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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis; Carotid Artery Disease
• Intervention / Treatment: Device: Carotid Artery Stenting

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.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Hawaii
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Carotid Artery Stenting; Carotid Artery Stenting with the GORE® Carotid Stent	Device: Carotid Artery Stenting; Carotid Artery Stenting with the GORE® Carotid Stent; Other Names: GORE® Carotid Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Stent Technical Success	Stent Technical Success defined as successful implantation of a GORE® Carotid Stent	Procedural
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success	EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.	Procedural
Number of Participants Who Achieved Procedure Success	Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.	Procedural
Number of Participants Who Experienced MAE at 30 Days	Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.	30 days
30-Day MAE - Death	Any cause death through 30 days post-index procedure	30 days
30-Day MAE - Myocardial Infarction	Any myocardial infarction through 30 days post-index procedure	30 days
30-Day MAE - Stroke	Any stroke through 30 days post-index procedure	30 days
In-Stent Restenosis	≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis	365 days
Target Lesion Revascularization	Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion	365 days

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Peter Schneider, MD, Kaiser Health System, Honolulu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (ESTIMATE): July 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Stent; Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Carotid Stenosis; Central Nervous System Diseases; Angioplasty; Brain Diseases; Cerebrovascular Disorders; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Artery Stenting (CAS); Embolic Protection Device (EPD); Constriction, Pathologic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Stenosis; Carotid Artery Diseases; Constriction, Pathologic
• Other Study ID Numbers: GCS 10-08