N/A
Completed N=312
The Gore SCAFFOLD Clinical Study
Source: ClinicalTrials.gov NCT01901874 ↗Enrolled (actual)
312
Serious AEs
39.3%
Results posted
May 2019
Primary outcomePrimary: Number of Participants Who Experienced Major Adverse Events (MAE) at One Year — 11 Participants — p=<0.00001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Major Adverse Events (MAE) at One Year |
11 | <0.00001 sig |
| SECONDARY Number of Participants Who Achieved Stent Technical Success |
265 | — |
| SECONDARY Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success |
251 | — |
| SECONDARY Number of Participants Who Achieved Procedure Success |
250 | — |
| SECONDARY Number of Participants Who Experienced MAE at 30 Days |
8 | — |
| SECONDARY 30-Day MAE - Death |
1 | — |
| SECONDARY 30-Day MAE - Myocardial Infarction |
4 | — |
| SECONDARY 30-Day MAE - Stroke |
3 | — |
| SECONDARY In-Stent Restenosis |
4 | — |
| SECONDARY Target Lesion Revascularization |
5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01901874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.