Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials

Conditions

Asymptomatic moderate to severe stenosis of the extracranial carotid artery Circulatory System Cerebrovascular diseases

Reiff T, Eckstein HH, Mansmann U, Jansen O, Fraedrich G, Mudra H, Böckler D, Böhm M, Debus ES, Fiehler J, Mathias K, Ringelstein EB, Schmidli J, Stingele R, Zahn R, Zeller T, Niesen WD, Barlinn K, Binder A, Glahn J, Hacke W, Ringleb PA, SPACE-2 Investigators.

2022-10-0178 citations

10.1016/s1474-4422(22)00290-3

Successful implementation of best medical treatment for patients with asymptomatic carotid artery stenosis within a randomized controlled trial (SPACE-2)

Tilman Reiff, Hans‐Henning Eckstein, Ulrich Mansmann, Olav Jansen, Gustav Fraedrich et al. (20 authors)

Neurological Research and Practice2021-10-1912 citations

10.1186/s42466-021-00153-w

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2

Tilman Reiff, Hans‐Henning Eckstein, Ulrich Mansmann, Olav Jansen, Gustav Fraedrich et al. (100 authors)

International Journal of Stroke2019-03-1585 citations

10.1177/1747493019833017

Interventions

Current interventions as of 19/12/2013: Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA (S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Sonographic identification of a more than or equal to 50% stenosis (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) of the extracranial carotid artery in a patient (both genders, age limit 85 years) without symptoms attributable to the target stenosis within the previous 180 days.

Exclusion criteria

Exclusion criteria: Non-atherosclerotic origin of carotid stenosis.

Design outcomes

Primary

Measure	Time frame
Cumulative rate of events consisting of: 1. Any stroke within 30 days of treatment 2. Death from any cause within 30 days 3. Ipsilateral ischaemic stroke within five years	—

Secondary

Measure	Time frame
1. All single components of the primary endpoint clusters 2. Any stroke, vascular death or myocardial infarction within 30 days (five years) 3. Any ischaemic stroke within 30 days (five years) 4. Disabling stroke within 30 days (five years) 5. Technical failure of intervention 6. Rate of re-stenosis (NASCET more than or equal to 50%) 7. Rate of myocardial infarction (30 days)	—

Countries

Austria, Germany, Switzerland

Outcome results

None listed