Carotid Endarterectomy vs. Repeated Carotid Angioplasty and Stenting for In-Stent Restenosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Ostrava

About this trial

Patients with in-stent restenosis in carotid artery indicated to carotid intervention will be randomized into repeated carotid percutaneous transluminal angioplasty with or without stenting or carotid endarterectomy with stent removal. The objective of the randomized study is to compare the safety and effectiveness of CEA and CAS in patients with in-stent restenosis of the ICA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

In-stent restenosis in carotid artery 70 - 99 %

Indication to carotid intervention

Age 18-80 years

Functionally independent with a modified Rankin score value of 0 - 2 points

Disqualifiers

Contraindication to general anesthesia

Contraindication to angiography (iodine allergy, etc.)

Technically impossible to perform angioplasty with or without stenting

Participation in other clinical study within 60 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carotid endarterectomy with stent removal

    Procedure/Surgery

    Standard carotid endarterectomy will be extended with the stent removal

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: carotid endarterectomyExperimental treatment 1 intervention
Group B: repeated angioplasty and stentingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

carotid stenosis

percentage of stenosis in treated carotid artery after intervention

Time frame
24 hours

Secondary outcomes

1

vascular morbidity within 30 days

ischemic stroke, hemorrhagic stroke, myocardial infarction and/or vascular death

Time frame
30 days

Other outcomes

Sponsors and contacts

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