Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
Conditions: Carotid Arteriosclerosis, Carotid Stenosis, Brain Stroke
Sponsor: Charles University, Czech Republic

Title: 
Residual Stenosis and Restenosis Following Carotid Endarterectomy with 
Primary Closure, A Prospective Tracking Study (RECEPT)
 
Introduction: 
According to current guidelines, carotid endarterectomy (CEA) with primary closure is 
associated with a higher incidence of residual stenosis and restenosis compared to the 
eversion technique (eCEA) and patch angioplasty (pCEA). A Cochrane database analysis 
reported restenosis (defined as ≥50% stenosis) in 26% of patients after CEA, 18% after 
eCEA, and 19% after pCEA. However, no significant difference was observed in the 
incidence of high-grade restenosis (≥70%). (Cheng, 2021) 
Nevertheless, the reported incidence of restenosis following CEA varies significantly across 
studies, ranging from 2% to 34%. These discrepancies are attributable to variations in surgical 
technique, study methodologies, and diagnostic protocols. 
Given the considerable body of literature on carotid restenosis, several terms have emerged to 
describe it based on timing and histological features. Most authors agree that stenosis 
occurring within 6 weeks (or 30 days) after surgery is classified as residual stenosis, 
representing a technical failure rather than a true recurrence. Early restenosis (typically 
within 3–18 months) is generally attributed to neointimal hyperplasia, while late restenosis 
(18–60 months post-op) is usually due to progressive atherosclerosis. 
As illustrated in the Kaplan–Meier curves below, the highest risk period for restenosis is 
during the early phase. Residual stenosis is observed in 4–6% of cases, early restenosis in 7–
11%, and late restenosis in 2–5%. (Moore, 1998) 
 
 

 
 
Figures 1–3: 
Kaplan–Meier curves showing the proportion of patients free from new stenosis over time. Y-
axis = number of days. 
Study Objective: 
The objective of this study is to assess the true incidence of restenosis following CEA in the 
Czech Republic. A major advantage of this study is the use of standardized surgical 
procedures across participating centers, along with unified data collection methods and 
diagnostic algorithms. 
 
Methodology: 
Patient Cohort: 
All patients meeting the current guideline indications for CEA will be enrolled. 
Exclusion criteria include: 
• 
Age ≤18 or ≥90 years 
• 
Previous endarterectomy or stenting 
• 
Unsuitable vascular anatomy 
• 
High perioperative risk 
• 
Contralateral cranial nerve X or XII palsy 
• 
History of neck irradiation 
• 
Tandem carotid stenosis or intracranial vascular pathology (e.g., aneurysm or AVM) 

• 
Absence of signed informed consent 
Collected data will include: 
• 
Epidemiologic risk factors: age, sex, diabetes, hypertension, dyslipidemia, metabolic 
syndrome, renal insufficiency, smoking, physical activity, weight, comorbidities 
• 
Laboratory markers: LDL, HDL, cholesterol, lipoprotein A, triglycerides, CKD-EPI, 
sedimentation rate, fibrinogen, INR (Quick test), APTT 
 
Diagnostics: 
All patients will undergo non-contrast brain CT. Carotid stenosis will be assessed by CT 
angiography performed within 3 months prior to surgery. In addition to stenosis severity, the 
degree of calcification will be classified as: 
• 
No calcification 
• 
Minimal 
• 
Partially calcified 
• 
Pronounced 
• 
Severe/unable to evaluate 
Other vascular pathology will also be recorded. Follow-up imaging will be performed at 1 
month, 1 year, and 3 years postoperatively. CT findings will be assessed by two independent 
reviewers. 
 
Surgical Technique: 
All patients will receive mono- or dual antiplatelet therapy, and 5,000 IU of heparin will be 
administered intraoperatively. Surgery may be performed under general anesthesia with 
electrophysiological monitoring or under local anesthesia, based on the surgeon’s preference. 
A longitudinal incision will be made anterior to the sternocleidomastoid muscle. The common 
carotid artery and its branches will be dissected and clamped. The internal carotid artery will 
be clamped distal to the most significant stenosis, as identified on preoperative CTA. The 
surgeon will incise through the tunica adventitia and media to expose and excise the 
atherosclerotic plaque. Any residual fragments will be removed, and the arterial wall will be 
closed using 6/0 suture. 
 
Follow-Up: 
Patients will continue on mono- or dual antiplatelet therapy. Mandatory follow-up CT 
angiography will be performed at 30 days, 1 year, and 3 years. During follow-up, the 
following will be evaluated: 

• 
CTA findings 
• 
Overall patient condition 
• 
Incidence of ischemic stroke (iCMP), TIA, myocardial infarction, and death 
 
Outcomes: 
Primary Outcome: 
• 
Restenosis ≥50% at 12 months 
Secondary Outcomes: 
• 
Residual stenosis ≥50% at 30 days 
• 
iCMP/TIA/death/MI 
• 
Change in modified Rankin Scale (mRS) 
 
Timeline: 
All participating centers (ÚVN, ČB, ÚNL, Poruba, Plzeň, Liberec, Vinohrady, Zlín, 
Olomouc, Hradec Králové, Fifejdy) together treat approximately 600–700 patients annually. 
An estimated 350 patients will be enrolled within 6 months. 
By the end of 2025, 300 patients will be included (expected dropout: 50). 
This will allow evaluation of: 
• 
Secondary outcomes in all 300 patients 
• 
Primary outcome in approximately 8 out of 26 centers (those with complete 12-month 
data) 
 
Ethical Approval: 
All participating centers have received approval from their respective institutional ethics 
committees. 
 
Funding: 
This study is conducted without external financial support.