The Gore SCAFFOLD Clinical Study

Carotid Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901874
• Other study ID #: GCS 10-08
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 2020

Study information

• Verified date: October 2020
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Device:
• Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent

Locations

Country	Name	City	State
United States	Kaiser Permanente Hawaii	Honolulu	Hawaii
United States	Lankenau Heart Institute	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Achieved Stent Technical Success	Stent Technical Success defined as successful implantation of a GORE® Carotid Stent	Procedural
Secondary	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
Secondary	Number of Participants Who Achieved Procedure Success	Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.	Procedural
Secondary	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
Secondary	30-Day MAE - Death	Any cause death through 30 days post-index procedure	30 days
Secondary	30-Day MAE - Myocardial Infarction	Any myocardial infarction through 30 days post-index procedure	30 days
Secondary	30-Day MAE - Stroke	Any stroke through 30 days post-index procedure	30 days
Secondary	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
Secondary	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