Stent-protected Percutaneous Angioplasty of the Carotid artery versus Endarterectomy

Conditions

Stroke, secondary prevention Circulatory System Stroke

Virginia J. Howard, Ale Algra, George Howard, Leo H. Bonati, Gert J. de Borst et al. (17 authors)

Stroke2021-01-2515 citations

10.1161/strokeaha.120.030184

Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis.

Müller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH.

2019-08-0511 citations

10.1161/circinterventions.119.007870

Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

Mandy D. Müller, Stefanie von Felten, Ale Algra, Jean‐Pierre Becquemin, Martin M. Brown et al. (18 authors)

Stroke2018-10-1536 citations

10.1161/strokeaha.118.020684

Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery

Barbara Rantner, Barbara Kollerits, Gary S. Roubin, Peter A. Ringleb, O Jansen et al. (19 authors)

Stroke2017-04-2997 citations

10.1161/strokeaha.116.016233

Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study.

Stingele R, Berger J, Alfke K, Eckstein HH, Fraedrich G, Allenberg J, Hartmann M, Ringleb PA, Fiehler J, SPACE investigators, Bruckmann H, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Zeumer H, Hacke W.

2008-01-31112 citations

10.1016/s1474-4422(08)70024-3

30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.

SPACE Collaborative Group, Ringleb PA, Allenberg J, Brückmann H, Eckstein HH, Fraedrich G, Hartmann M, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Stingele R, Zeumer H, Hacke W.

2006-10-01874 citations

10.1016/s0140-6736(06)69122-8

Interventions

Carotid endarterectomy or Carotid artery stenting

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
1. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding) or vascular death within the follow-up period of 24 months, beginning with the time of randomisation 2. Restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET after 6, 12 and 24 months 3. Procedural technical failure (technically not feasible treatment, serious adverse events [SAE] during and/or by the treatment, occlusion of the vessel or restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET on the 6th day ± 1 day and 30th day ± 3 day after treatment) 4. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding with an impairment =3 on the modified Rankin scale) or death of every cause, between randomisation and day 30 ± 3 after treatment 5. Strokes of every localisation and severity 30 ± 3 days after the intervention 6. Strokes of every localisation and severity within 24 months ± 14 days after the intervention	—

Measure

Time frame

1. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding) or vascular death within the follow-up period of 24 months, beginning with the time of randomisation 2. Restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET after 6, 12 and 24 months 3. Procedural technical failure (technically not feasible treatment, serious adverse events [SAE] during and/or by the treatment, occlusion of the vessel or restenosis with at least 70% measured by Duplexsonography according to 70%-stenosis following the ECST-criteria or at least a 50%-stenosis after the criteria of the NASCET on the 6th day ± 1 day and 30th day ± 3 day after treatment) 4. Ipsilateral stroke (ischaemic stroke and/or intracerebral bleeding with an impairment =3 on the modified Rankin scale) or death of every cause, between randomisation and day 30 ± 3 after treatment 5. Strokes of every localisation and severity 30 ± 3 days after the intervention 6. Strokes of every localisation and severity within 24 months ± 14 days after the intervention

—

Countries

Germany

Outcome results

None listed