Carotid Artery DiseaseNCT01901874

The Gore SCAFFOLD Clinical Study

A study testing Carotid Artery Stenting in people with Carotid Artery Disease and Carotid Artery Stenosis, run by W.L.Gore & Associates at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Artery Disease, Carotid Artery Stenosis
What is being tested?: Carotid Artery Stenting
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 312 participants
Where: 2 sitesUnited States
Study dates: Jul 2013to Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this 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

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

Read the 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.

Conditions: Carotid Artery Disease, Carotid Artery Stenosis
Being tested: Carotid Artery Stenting
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
Medical subject headings: Carotid Artery Diseases, Carotid Stenosis, Stroke, Constriction, Pathologic, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotid Artery StentingDevice
Also called GORE® Carotid Stent
Carotid Artery Stenting with the GORE® Carotid Stent

Study groups in NCT01901874
Study group	Role	What they receive
Carotid Artery Stenting	Experimental	Carotid Artery Stenting with the GORE® Carotid Stent Receives: Device: Carotid Artery Stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 365 days

Secondary outcomes (9)

Number of Participants Who Achieved Stent Technical Success
Stent Technical Success defined as successful implantation of a GORE® Carotid Stent
Measured: 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.
Measured: Procedural
Number of Participants Who Achieved Procedure Success
Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.
Measured: Procedural
Number of Participants Who Experienced MAE at 30 Days
Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.
Measured: 30 days
30-Day MAE - Death
Any cause death through 30 days post-index procedure
Measured: 30 days
30-Day MAE - Myocardial Infarction
Any myocardial infarction through 30 days post-index procedure
Measured: 30 days
30-Day MAE - Stroke
Any stroke through 30 days post-index procedure
Measured: 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
Measured: 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
Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Sep 2020

First posted17 Jul 2013 (estimated)
Study startJul 2013
Primary completionDec 2017
Study completionSep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01901874
Sponsor's protocol ID: GCS 10-08
Status last verified: Oct 2020
First submitted: 12 Jul 2013
Last updated: 29 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 31713310

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carotid Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01901874
Acronym / sponsor ID: GCS 10-08
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Jul 2013 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Sep 2020 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Carotid Artery Stenting	Experimental	Device: Carotid Artery StentingCarotid Artery Stenting with the GORE® Carotid Stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Patient must be considered high risk for adverse events during carotid endarterectomy

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carotid Artery StentingAlso: GORE® Carotid StentCarotid Artery Stenting with the GORE® Carotid Stent	Device	Carotid Artery Stenting

Primary outcome

Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
Time frame: 365 days
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).

9 secondary outcomes

Number of Participants Who Achieved Stent Technical Success
Time frame: Procedural
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
Time frame: Procedural
Number of Participants Who Achieved Procedure Success
Time frame: Procedural
Number of Participants Who Experienced MAE at 30 Days
Time frame: 30 days
30-Day MAE - Death
Time frame: 30 days
30-Day MAE - Myocardial Infarction
Time frame: 30 days
30-Day MAE - Stroke
Time frame: 30 days
In-Stent Restenosis
Time frame: 365 days
Target Lesion Revascularization
Time frame: 365 days

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carotid Artery Stenting	312	312

Primary outcome: Number of Participants Who Experienced Major Adverse Events (MAE) at One Year

Time frame: 365 days. Count of participants. Unit: Participants

Measure	Carotid Artery Stenting n = 244
Value	11

Carotid Artery Stenting: Weighted binomial proportion: 0.0448, p <0.00001, Binomial test (normal approximation)

Population analysed: Per protocol subjects with 1-year MAE evaluation

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 395 days (end of 1-year follow-up window). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carotid Artery Stenting	104 of 265 (39.2%)	110 of 265 (41.5%)	11 of 265

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31713310Gray 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.

Related trials for Carotid Artery Disease

RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Gray, MD principal investigator

Lankenau Heart Institute

Peter Schneider, MD principal investigator

Kaiser Health System, Honolulu

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Carotid Artery Stenting in people with Carotid Artery Disease and Carotid Artery Stenosis, run by W.L.Gore & Associates at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Major Adverse Events (MAE) at One Year (time frame: 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01901874, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.