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CompletedNCT01901874Updated Oct 29, 2020Results posted

The Gore SCAFFOLD Clinical Study

An interventional study of Carotid Artery Stenting in Carotid Artery Disease and Carotid Artery Stenosis, sponsored by W.L.Gore & Associates. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.

Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
312
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 312 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
312 participants (actual)

Study arms

  • Experimental
    Carotid Artery Stenting

    Carotid Artery Stenting with the GORE® Carotid Stent

    Device: Carotid Artery Stenting

Interventions

  • DeviceCarotid Artery Stenting

    Carotid Artery Stenting with the GORE® Carotid Stent

    Also known as: GORE® Carotid Stent

06

What researchers measure

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).

    Time frame: 365 days

Secondary outcomes

  1. Number of Participants Who Achieved Stent Technical Success

    Stent Technical Success defined as successful implantation of a GORE® Carotid Stent

    Time frame: Procedural

  2. 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.

    Time frame: Procedural

  3. Number of Participants Who Achieved Procedure Success

    Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE.

    Time frame: Procedural

  4. Number of Participants Who Experienced MAE at 30 Days

    Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.

    Time frame: 30 days

  5. 30-Day MAE - Death

    Any cause death through 30 days post-index procedure

    Time frame: 30 days

  6. 30-Day MAE - Myocardial Infarction

    Any myocardial infarction through 30 days post-index procedure

    Time frame: 30 days

  7. 30-Day MAE - Stroke

    Any stroke through 30 days post-index procedure

    Time frame: 30 days

  8. 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

    Time frame: 365 days

  9. 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

    Time frame: 365 days

07

Results

Posted May 3, 2019

Participant flow

Procedure
Participant flow — Procedure
MilestoneCarotid Artery Stenting
Started312
Completed312
Not completed0
Screening Committee Retrospective Review
Participant flow — Screening Committee Retrospective Review
MilestoneCarotid Artery Stenting
Started312
Completed265
Not completed47
Withdrew: Protocol violation47
30-Day MAE Evaluation
Participant flow — 30-Day MAE Evaluation
MilestoneCarotid Artery Stenting
Started265
Completed264
Not completed1
Withdrew: Insufficient follow-up1
1-Year (365-Day) MAE Evaluation
Participant flow — 1-Year (365-Day) MAE Evaluation
MilestoneCarotid Artery Stenting
Started264
Completed244
Not completed20
Withdrew: Death7
Withdrew: Lost to follow-up5
Withdrew: Withdrawal by subject2
Withdrew: Insufficient follow-up6

Outcome measures

PrimaryNumber 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).

Time frame:
365 days
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
ParticipantsCarotid Artery Stenting
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year11
Statistical analysis
  • Carotid Artery Stenting · Binomial test (normal approximation) · p = <0.00001 (A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.) · Weighted binomial proportion: 0.0448Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.
SecondaryNumber of Participants Who Achieved Stent Technical Success

Stent Technical Success defined as successful implantation of a GORE® Carotid Stent

Time frame:
Procedural
Reported as:
Count of participants · Participants
Number of Participants Who Achieved Stent Technical Success
ParticipantsCarotid Artery Stenting
Number of Participants Who Achieved Stent Technical Success265
SecondaryNumber 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.

Time frame:
Procedural
Reported as:
Count of participants · Participants
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
ParticipantsCarotid Artery Stenting
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success251
SecondaryNumber of Participants Who Achieved Procedure Success

Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE.

Time frame:
Procedural
Reported as:
Count of participants · Participants
Number of Participants Who Achieved Procedure Success
ParticipantsCarotid Artery Stenting
Number of Participants Who Achieved Procedure Success250
SecondaryNumber of Participants Who Experienced MAE at 30 Days

Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.

Time frame:
30 days
Reported as:
Count of participants · Participants
Number of Participants Who Experienced MAE at 30 Days
ParticipantsCarotid Artery Stenting
Number of Participants Who Experienced MAE at 30 Days8
Secondary30-Day MAE - Death

Any cause death through 30 days post-index procedure

Time frame:
30 days
Reported as:
Count of participants · Participants
30-Day MAE - Death
ParticipantsCarotid Artery Stenting
30-Day MAE - Death1
Secondary30-Day MAE - Myocardial Infarction

Any myocardial infarction through 30 days post-index procedure

Time frame:
30 days
Reported as:
Count of participants · Participants
30-Day MAE - Myocardial Infarction
ParticipantsCarotid Artery Stenting
30-Day MAE - Myocardial Infarction4
Secondary30-Day MAE - Stroke

Any stroke through 30 days post-index procedure

Time frame:
30 days
Reported as:
Count of participants · Participants
30-Day MAE - Stroke
ParticipantsCarotid Artery Stenting
30-Day MAE - Stroke3
SecondaryIn-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

Time frame:
365 days
Reported as:
Count of participants · Participants
In-Stent Restenosis
ParticipantsCarotid Artery Stenting
In-Stent Restenosis4
Statistical analysis
  • Carotid Artery Stenting · Cumulative probability: 0.018 · 95% CI 0.007 to 0.047Kaplan-Meier product-limit method (Greenwood's formula for standard error)
SecondaryTarget 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

Time frame:
365 days
Reported as:
Count of participants · Participants
Target Lesion Revascularization
ParticipantsCarotid Artery Stenting
Target Lesion Revascularization5
Statistical analysis
  • Carotid Artery Stenting · Cumulative probability: 0.022 · 95% CI 0.009 to 0.052Kaplan-Meier product-limit method (Greenwood's formula for standard error)

Adverse events

Collected over 395 days (end of 1-year follow-up window). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Carotid Artery Stenting11/265 (4.2%)104/265 (39.2%)110/265 (41.5%)
Most frequent serious events
Showing 10 of 104
Most frequent serious events
EventCarotid Artery Stenting
Vascular stent restenosisGeneral disorders10/265
PneumoniaInfections and infestations10/265
Carotid artery stenosisNervous system disorders9/265
HypotensionVascular disorders9/265
Cerebrovascular accidentNervous system disorders6/265
Angina pectorisCardiac disorders5/265
Coronary artery diseaseCardiac disorders5/265
AnaemiaBlood and lymphatic system disorders4/265
Acute myocardial infarctionCardiac disorders4/265
Gastrointestinal haemorrhageGastrointestinal disorders4/265
Most frequent other events
Showing 10 of 31
Most frequent other events
EventCarotid Artery Stenting
HypotensionVascular disorders24/265
Urinary tract infectionInfections and infestations14/265
HeadacheNervous system disorders14/265
BradycardiaCardiac disorders9/265
DyspnoeaRespiratory, thoracic and mediastinal disorders9/265
HypertensionVascular disorders9/265
Incision site haemorrhageInjury, poisoning and procedural complications8/265
DizzinessNervous system disorders8/265
AnaemiaBlood and lymphatic system disorders6/265
FatigueGeneral disorders6/265

Baseline characteristics

Per protocol subjects

Age, Continuous
Age, Continuous(years)Carotid Artery Stenting
Mean73.1 ± 8.8
Age, Continuous
Age, Continuous(years)Carotid Artery Stenting
Median74.4 (45.8 to 92.8)
Sex: Female, Male
Sex: Female, Male(Participants)Carotid Artery Stenting
Female89
Male176
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Carotid Artery Stenting
Hispanic or Latino5
Not Hispanic or Latino258
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Carotid Artery Stenting
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American7
White252
More than one race3
Unknown or Not Reported0
Diabetes Mellitus
Diabetes Mellitus(Participants)Carotid Artery Stenting
Count of participants107
Hypertension
Hypertension(Participants)Carotid Artery Stenting
Count of participants249
Cigarette Smoking
Cigarette Smoking(Participants)Carotid Artery Stenting
Current or stopped <12 months ago67
Previous (stopped >12 months ago)139
Never59

10 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Kaiser Permanente Hawaii
    Honolulu, Hawaii 96819, United States
  • Lankenau Heart Institute
    Wynnewood, Pennsylvania 19096, United States
09

References and documents

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 ↗

Study documents

  • Study protocol · Oct 22, 2014
  • Statistical analysis plan · Jun 10, 2014

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01901874
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Jul 17, 2013
Start date
Jul 2013
Primary completion
Dec 2017
Completion
Sep 2020
Results posted
May 3, 2019
Last update
Oct 29, 2020

Study contacts

William Gray, MD
principal investigator · Lankenau Heart Institute
Peter Schneider, MD
principal investigator · Kaiser Health System, Honolulu

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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