Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02)

Inclusion Criteria:

1. Signed written informed consent

2. Target population

- Diagnosis:

- Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography)

- Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria

- TIA, amaurosis fugax or stroke within the last 30 days

- Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised.

Exclusion Criteria:

1. Sex and reproductive Status:

- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.

- Women who are pregnant or breastfeeding

- Women with a positive pregnancy test on enrollment or prior to investigational product administration.

2. Target disease exceptions

- NIHSS score > 18

- Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR)

- Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves)

3. Medical history and concurrent disease

- History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug

- History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT))

- Thrombolysis within the last 48 hours

- Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis

- Oral anticoagulation or dual anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)

- Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg)

- History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis

- Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit)

- Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis

- Known atrial fibrillation or other clinically significant ECG abnormalities (at present)