Multicenter Evaluation of a Self-Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis

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Fig 1.
The Interceptor distal embolic protection device. A, Closed (0.0039-inch crossing profile). B, Open, showing the 1800-μm proximal openings.
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Fig 2.
Percent diameter stenosis in carotid arteries over time, as determined by sonography evaluation (core laboratory analysis). prox, proximal; dist, distal. The following criteria were used for determination of %DS: PSV (peak systolic velocity) ≤ 125 cm/s: <49% DS; PSV > 125 cm/s and EDV (end diastolic velocity) ≤ 140 cm/s: 50%–79% DS; PSV > 125 cm/s and EDV > 140 cm/s: 80%–99% DS; no flow in ICA: 100% DS.
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Fig 3.
Particulate size distribution results compared with GuardWire+ positive controls.
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Fig 4.
H&E staining of particulate demonstrating diverse cellular elements including macrophages and foam cells (200×).

Table 1:

Definitions of high-risk patients

Anatomic Risk Factors	Comorbidity Risk Factors
Anatomic Risk Factors	Group A	Group B
Previous carotid endarterectomy	Patients >80 years of age	NYHA class III or IV heart failure
Contralateral carotid artery occlusion
Previous radical neck dissection or radiation therapy to neck region	MI within previous 6 weeks
Target lesion above C2 (level of jaw)		COPD with FEV₁ <30% predicted
Low cervical carotid lesions
Dissection	Unstable angina (according to Braunwald classification)
Inability to extend neck (ie, cervical osteoarthritis, mobility limitations)		History of liver failure with elevated prothrombin time
Tandem lesions ≥70% stenosis	Elective CABG scheduled minimally 30 days after the carotid stenting procedure
Contralateral laryngeal palsy
At risk for wound infection
Tracheostomy	Severe renal failure defined as a serum creatine >2 mg/dL

Note:—Patients are at high risk if they have (1) one or more anatomic risk factors, (2) one co-morbidity (group A) risk factor, or (3) one or more co-morbidity (group B) risk factors. NYHA indicates New York Heart Association; COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 second; CABG, coronary artery bypass grafting.

Table 2:

Patient baseline characteristics

Patient characteristics (n = 51)
Age ± SD (y)	69 ± 11
Male, n (%)	43 (84.3)
Hypertension, n (%)	36 (70.6)
Hypercholesterolemia, n (%)	33 (64.7)
Diabetes, n (%)	12 (23.5)
Current smoker, n (%)	5 (9.8)
Family history of cardiovascular disease, n (%)	15 (29.4)
Risk factors for carotid endarterectomy
Previous carotid endarterectomy, n (%)	15 (29.4)
Contralateral carotid artery occlusion, n (%)	14 (27.5)
Previous radical neck dissection or radiation therapy in neck region, n (%)	6 (11.8)
Target lesion above C2 (level of jaw), n (%)	2 (3.9)
Low cervical carotid lesions, n (%)	2 (3.9)
Dissection, n (%)	0 (0.0)
Inability to extend the neck, n (%)	2 (3.9)
Tandem lesions ≥70% stenosis, n (%)	6 (11.8)
Contralateral laryngeal palsy, n (%)	0 (0.0)
At risk for wound infection, n (%)	0 (0.0)
Tracheostomy, n (%)	2 (3.9)
Patients >80 years of age, n (%)	8 (15.7)
Myocardial infarction within previous 6 weeks, n (%)	1 (2.0)
Unstable angina (according to Braunwald classification), n (%)	5 (9.8)
Severe renal failure (serum creatinine >2 mg/dL), n (%)	0 (0.0)
Elective coronary artery bypass grafting scheduled (≥30 days after procedure), n (%)	1 (2.0)
New York Heart Association class III or IV heart failure, n (%)	7 (13.7)
COPD with FEV₁ <30% predicted, n (%)	2 (3.9)
History of liver failure with elevated prothrombin time	0 (0.0)

Note:—COPD indicates chronic obstructive pulmonary disease; FEV₁, forced expiration volume in 1 second.

Table 3:

Lesion and angiographic characteristics as assessed by core laboratory

		N
Preprocedure diamater stenosis (%DS)
Mean ± SD	62.37 ± 10.46	45
Range (min, max)	41.81, 81.19
Postprocedure diameter stenosis (%DS)
Mean ± SD	21.16 ± 13.37	48
Range (min, max)	−5.73, 51.38
Target lesion vessel (%)
Common carotid artery	10	5
Internal carotid artery	90	46
External carotid artery	0	0
Acute gain (mm)	42.11 ± 14.40	42

Table 4:

Cumulative incidence of major adverse events