Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy

Not Applicable

Completed

• Conditions: Stroke, secondary prevention; Circulatory System; Stroke

• Registration Number: ISRCTN57874028
• Lead Sponsor: Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)

Brief Summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15178989 2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23237679 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30355202 4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31378071 (added 06/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-02
• Study Completion: 2005-12-31
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

a. Symptomatic (Amaurosis fugax, transient ischemic attack [TIA], prolonged reversible ischaemic neurologic deficit [PRIND], complete stroke), Stenosis of the carotid bifurcation or the internal carotid artery (ICA) within 180 days before randomisation
b. Clinical impairment not more than 3 of the modified Rankin scale
c. Age at least 50 years
d. Negative pregnancy test for women with childbearing potential
e. Possibility to participate on the follow-up visits
f. Written informed consent
g. Stenosis of the carotid bifurcation or the ICA on the clinically symptomatic side with at least 70% according the criteria of the European Carotid Surgery Trial (ECST) or at least 50% after the criteria of the NASCET

Exclusion Criteria

a. Intracranial bleeding within the last 90 days before treatment
b. Uncontrolled hypertension
c. Proved intracranial vessel malformation (aneurysm or arteriovenous malformation [AVM])
d. Known cardiac cause of thromboembolism
e. Concomittant disease that will prevent the patient from attending follow up or known malignancy
f. Not correctable coagulation abnormality
g. Contraindication against Heparin, acetylsalicylic acid (ASA), Ticlopidine, or Clopidogrel
h. Contraindication against contrast medium
i. Occlusion of the common carotid artery (CCA) or ICA
j. Stenosis by an external compression (e.g. by tumour)
k. Stenosis caused by dissection
l. Restenosis after surgical or endovascular treatment
m. Radiation-induced stenosis
n. Fibromuscular dysplasia
o. Thrombusformation within the stenosis
p. Tandemstenosis if the distal stenosis is more severe than the proximal one
q. Planned simultaneous surgical procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of an ipsilateral stroke (ischaemic stroke and/or intracerebrale bleeding with symptoms lasting more than 24 hours) or the death of every cause, between randomisation and day 30