The clear-road study: Evaluation of a new dual layer micromesh stent system for the carotid artery

EuroIntervention

Volumn 12, Issue 5, 2016, Pages e671-e676

  Bosiers, Marc ^a   Deloose, Koen ^a   Torsello, Giovanni ^b   Scheinert, Dierk ^c   Maene, Lieven ^d   Peeters, Patrick ^e   Müller Hülsbeck, Stefan ^f   Sievert, Horst ^g   Langhoff, Ralf ^h   Bosiers, Michel ^b   Setacci, Carlo ⁱ  

^a AZ Sint Blasius ^*  (Belgium)

^b UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^c UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^d OLV HOSPITAL   (Belgium)

^e IMELDA HOSPITAL   (Belgium)

^f Diako Hospital   (Germany)

^g CARDIOVASCULAR CENTER FRANKFURT   (Germany)

^h MARTIN LUTHER KRANKENHAUS   (Germany)

ⁱ UNIVERSITY OF SIENA   (Italy)

Author keywords

Bare metal stent; Carotid and supra aortic disease; Death; Myocardial infarction; Stroke

Indexed keywords

WARFARIN;

AGED; ARTICLE; ATRIAL FIBRILLATION; CARDIOVASCULAR RESPONSE; CAROTID ARTERY STENT; CAROTID ENDARTERECTOMY; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; EMBOLIC PROTECTION DEVICE; FEMALE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; PROSPECTIVE STUDY; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME; VERY ELDERLY; ANGIOPLASTY; CAROTID STENOSIS; COMMON CAROTID ARTERY; MYOCARDIAL INFARCTION; PROCEDURES; PROSTHESIS DESIGN; STROKE; SURGERY;

AGED, 80 AND OVER; ANGIOPLASTY; CAROTID ARTERY, COMMON; CAROTID STENOSIS; EMBOLIC PROTECTION DEVICES; ENDARTERECTOMY, CAROTID; FEMALE; HUMANS; MALE; MYOCARDIAL INFARCTION; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; STROKE; TREATMENT OUTCOME;

EID: 84983748382     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY16M05_04     Document Type: Article

References (20)

1. Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W; ACT I Investigators. Randomzied Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016;374: 1011-20.
2. Brott TG. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11-23.
3. Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351:1493-501.
4. Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JP, Lal BK, Meschia JF; CREST Investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11-23.
5. Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke. 2005;36:905-11.
6. Bates ER, Babb JD, Casey DE Jr, Cates CU, Duckwiler GR, Feldman TE, Gray WA, Ouriel K, Peterson ED, Rosenfield K, Rundback JH, Safian RD, Sloan MA, White CJ. ACCF/SCAI/SVMB/SIR/ ASITN 2007 clinical expert consensus document on carotid stenting: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/ SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting). J Am Coll Cardiol. 2007;49:126-70.
7. Bosiers M, Deloose K, Verbist J, Peeters P. What practical factors guide the choice of stent and protection device during carotid angioplasty? Eur J Vasc Endovasc Surg. 2008;35:637-43.
8. Schofer J, Musiaek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. A Prospective, Multicenter study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). JACC Cardiovasc Interv. 2015;8:1229-34.
9. Hopf-Jensen S, Marques L, Preiβ M, Müller-Hülsbeck S. Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Ther. 2015:22:220-5.
10. Wissgott C, Schmidt W, Brandt C, Behrens P, Andresen R. Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. J Endovasc Ther. 2015;22:634-9.
11. Sangiorgi G, Colombo A. Embolic protection devices. Heart. 2003;89:990-2.
12. Müller-Hülsbeck S. [Cerebral protection devices for treatment of carotid stenoses: Where do we stand today?] [Article in German]. Rofo. 2002;174:945-54.
13. Ohki T, Veith FJ. Critical analysis of distal protection devices. Semin Vascular Surgery. 2003;16:317-25.
14. Tietke M, Jansen O. Cerebral protection vs no cerebral protection: timing of stroke with CAS. J Cardiovasc Surg (Torino). 2009;50:751-60.
15. Featherstone RL, Dobson J, Ederle J, Doig D, Bonati LH, Morris S, Patel NV, Brown MM. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): a randomized controlled trial with cost-effectiveness analysis. Health Technol Assess. 2016;20;1-94.
16. Fairman R., Gray WA, Scicli AP, Wilburn O, Verta P, Atkinson R, Yadav JS, Wholey M, Hopkins LN, Raabe R, Barnwell S, Green R. The Capture Registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity and type. Ann Surg. 2007;246:551-6; discussion 556-8.
17. Hong MK, Mintz GS, Lee CW, Kim YH, Lee SW, Song JM, Han K, Kang DH, Song JK, Kim JJ, Park SW, Park SJ. Incidence, mechanism, predictors and long-term prognosis of late stent malapposition after bare-metal stent implantation. Circulation. 2004;109:881-6.
18. Duda SH, Wiskirchen J, Tepe G, Bitzer M, Kaulich TW, Stoeckel D, Claussen CD. Physical properties of endovascular stents: an experimental comparison. J Vasc Interv Radiol. 2000;11:645-54.
19. Müller-Hülsbeck S, Schäfer PJ, Charalambous N, Schaffner SR, Heller M, Jahnke T. Comparison of carotid stents: an in-vitro experiment focusing on stent design. J Endovasc Ther. 2009;16:168-77.
20. Hopf-Jensen S, Marques L, Preib M, Müller-Hülsbeck S. Lesion-Related Carotid Angioplasty and Stenting with Closed-Cell Design without Embolic Protection Devices in High-Risk Elderly Eatients-Can This Concept Work Out? A Single Center Experience Focusing on Stent Design. Int J Angiol. 2014;23:263-70.