Development of microporous covered stents: Geometrical design of the luminal surface

International Journal of Artificial Organs

Volumn 28, Issue 6, 2005, Pages 600-608

  Nakayama, Yasuhide ^a   Nishi, S ^b   Ishibashi Ueda, H ^a   Okamoto, Y ^c   Nemoto, Y ^c  

^a NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^b TAKATSUKI RED CROSS HOSPITAL   (Japan)

^c BRIDGESTONE CORPORATION   (Japan)

Author keywords

Covered stents; Drug eluting; Flat luminal surface; Micropore; Stents

Indexed keywords

MICROPOROSITY;

COVERED STENTS; DRUG-ELUTING; FLAT LUMENAL SURFACE; GEOMETRICAL DESIGNS; IN-STENT RESTENOSIS; MICROPORES; MICROPOROUS; PHYSICAL BARRIERS; RESTENOSIS RATES; TISSUE IN-GROWTH;

STENTS;

ELASTOMER; POLYURETHAN; STAINLESS STEEL;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BALLOON CATHETER; CAROTID ARTERIOGRAPHY; CAROTID ARTERY THROMBOSIS; COMMON CAROTID ARTERY; DRUG ELUTING STENT; EQUIPMENT DESIGN; EXCIMER LASER; GEOMETRY; IN-STENT RESTENOSIS; INTIMA; NONHUMAN; POROSITY; RABBIT; STENT;

EID: 23144435389     PISSN: 03913988     EISSN: None     Source Type: Journal    
DOI: 10.1177/039139880502800609     Document Type: Article

References (56)

1. Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilation of coronary-artery stenosis: Percutaneous transluminal coronary angioplasty. N Engl J Med 1979; 301: 61-8.
2. Lee G, Ikeda RM, Joye JA, Bogren HG, DeMaria AN, Mason DT. Evaluation of transluminal angioplasty of chronic coronary artery stenosis. Value and limitations assessed in fresh human cadaver hearts. Circulation 1980; 61: 77-83.
3. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intervascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316: 701-6.
4. Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy JJ, van der Heuvel P, Delcan J, Morel MA. A comparison of balloon-expandable stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994; 331: 489-95.
5. Fiscman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994; 331: 496-501.
6. Erbel R, Haude M, Hopp HW, Franzen D, Rupprecht HJ, Heublein B, Fisher K, de Jaegere P, Serruys P, Rutsch W, Probst P. Coronary-artery stenting compared with balloon angioplasty for restenosis after intimal balloon angioplasty. N Engl J Med 1998; 339: 1672-8.
7. Nakayama Y, Ji-Youn K, Nishi S, Ueno H, Matsuda T. Development of high-performance stent: Gelatinous photogel-coated stent that permits drug delivery and 12 gene transfer. J Biomed Mater Res 2001; 57: 559-66.
8. Holmes DR, Camrud AR, Jorgenson MA, Edwards WD, Schwartz RS. Polymeric stenting in the porcine coronary artery model: Differential outcome of exogenous fibrin sleeves versus polyurethane-coated stents. J Am Coll Cardiol 1994; 24: 525-31.
9. Severini A, Mantero S, Tanzi MC, Cigada A, Salvetti M, Cozzi G, Motta A. Polyurethane-coated, self-expandable biliary stent: An experimental study. Acad Radiol 1995; 2: 1078-81.
10. Castaneda F, Ball SM, Wyffels PL, Young K, Li R. Assessment of a polyester-covered nitinol stent in an atherosclerotic swine model. J Vasc Interv Radiol 2000; 11: 483-91.
11. Schellhammer F, Berlis A, Bloss H, Pagenstecher A, Schumacher M. Poly-lactic-acid coating for endovascular stents. Preliminary results in canine experimental arteriovenous fistulae. Invest Radiol 1997; 32: 180-6.
12. Hietala EM, Salminen US, Stahls A, Valimaa T, Maasilta P, Tormala P, Nieminen MS, Harjula AL. Biodegradation of the copolymeric polylactide stent. Long-term follow-up in a rabbit aorta model. J Vasc Res 2001; 38: 361-9.
13. Tamai H, Igaki K, Kyo E, Kosuga K, Kawashima A, Matsui S, Komori H, Tsuji T, Motohara S, Uehata H. Initial and 6-month results of biodegradable poly-I-lactic acid coronary stents in humans. Circulation 2000; 102: 399-404.
14. Petas A, Vuopio-Varkila J, Siitonen A, Valimaa T, Talja M, Taari K. Bacterial adherence to self-reinforced polyglycolic acid and self-reinforced polylactic acid 96 urological spiral stents in vitro. Biomaterials 1998; 19: 677-81.
15. Ozbek C, Heisel A, Gross B, Bay W, Schieffer H. Coronary implantation of siliconecarbide-coated Palmaz-Schatz stents in patients with high risk of stent thrombosis without oral anticoagulation. Cathet Cardiovasc Diagn 1997; 41: 71-8.
16. Lahann J, Klee D, Pluester W, Hoecker H. Bioactive immobilization of γ-hirudin on CVD-coated metallic implant devices. Biomaterials 2001; 22: 817-26.
17. de Smet BJ, de Kleijn D, Hanemaaijer R, Verheijen JH, Robertus L, van Der Helm YJ, Borst C, Post MJ. Metalloproteinase inhibition reduces constrictive arterial remodeling after balloon angioplasty: A study in the atherosclerotic Yucatan micropig. Circulation 2000; 101, 2962-7.
18. Cherr GS, Motew SJ, Travis JA, Fingerle J, Fisher L, Brandl M, Williams JK, Geary RL. Metalloproteinase inhibition and the response to angioplasty and stenting in atherosclerotic primates. Arterioscler Thromb Vasc Biol 2002; 22: 161-6.
19. Lincoff AM, Furst JG, Ellis SG, Tuch RJ, Topol EJ. Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model. J Am Coll Cardiol 1997; 29: 808-16.
20. Yamawaki T, Shimokawa H, Kozai T, Miyata K, Higo T, Tanaka E, Egashira K, Shiraishi T, Tamai H, Igaki K, Takrshita A. Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo. J Am Coll Cardiol 1998; 32: 780-6.
21. Lambert TL, Dev V, Rechavia E, Forrester JS, Litvack F, Eigler NL. Localized arterial wall drug delivery from a polymer-coated removable metallic stent. Kinetics, distribution, and bioactivity of forskolin. Circulation 1994; 90: 1003-11.
22. Farb A, Heller PF, Shroff S, Cheng L, Kolodgie FD, Carter AJ, Scott DS, Froehlich J, Virmani R. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 2001; 104: 473-9.
23. Heldman AW, Cheng L, Jenkins GM,, Heller PF, Kim DW, Ware M Jr, Nater C, Hruban RH, Rezai B, Abella BS, Bunge KE, Kinsella JL, Sollott SJ, Lakatta EG, Brinker JA, Hunter WL, Froehlich JP. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation 2001; 103: 2289-95.
24. Hardhammar PA, van Beusekom HMM, Emanuelesson HU, Hofma SH, Albertsson PA, Verdouw PD, Boersma E, Serruys PW, van der Giessen WJ. Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal porcine coronary arteries. Circulation 1996; 93: 423-30.
25. Blezer R, Cahalan L, Cahalan PT, Lindhout T. Heparin coating of tantalum coronary stents; reduces surface thrombin generation but not factor IXa generation. Blood Coagul Fibrinolysis 1998; 9: 435-40.
26. van Der Giessen WJ, van Beusekom HM, Larsson R, Serruys P. Heparin-coated coronary stents. Curr Interv Cardiol Rep 1999; 1: 234-40.
27. Beythien C, Gutensohn K, Bau J, Hamm CW, Kuhnl P, Meinertz T, Terres W. Influence of stent length and heparin coating on platelet activation: A flow cytometric analysis in a pulsed floating model. Thromb Res 1999; 94: 79-86.
28. Vrolix MC, Legrand VM, Reiber JH, Grollier G, Schalij MJ, Brunei P, Martinez-Elbal L, Gomez-Recio M, Bar FW, Bertrand ME, Colombo A, Brachman J. Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators. Am J Cardiol 2000; 86: 385-9.
29. Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: One year angiographic and intravascular ultrasound follow-up. Circulation 2001; 104: 2007-11.
30. Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: A quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 2001; 103: 192-5.
31. Kastrati A, Schomig A, Dirschinger J, Mehilli J, von Welser N, Pache J, Schuhlen H, Schilling T, Schmitt C, Neumann FJ. Increased risk of restenosis after placement of gold-coated stents: Results of a randomized trial comparing gold-coated with uncoated steel stents in patients with coronary artery disease. Circulation 2000; 30: 2478-83.
32. Edelman ER, Seifert P, Groothuis A, Morss A, Bornstein D, Rogers C. Gold-coated NIR stents in porcine coronary arteries. Circulation 2001; 103: 429-34.
33. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R, RAVEL Study Group. Randomized study with the sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346: 1773-80.
34. Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ. SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: Serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol 2004; 43: 1959-63.
35. Doggrell SA. Sirolimus- versus paclitaxel-eluting stents in patients with stenosis in a native coronary artery. Expert Opin Pharmacother 2004; 5: 1431-4.
36. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: The TAXUS-IV trial. Circulation 2004; 109: 1942-7.
37. Tanabe K, Serruys PW, Degertekin M, Guagliumi G, Grube E, Chan C, Munzel T, Belardi J, Ruzyllo W, Bilodeau L, Kelbaek H, Ormiston J, Dawkins K, Roy L, Strauss BH, Disco C, Koglin J, Russell ME, Colombo A. TAXUS II Study Group. Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: Comparison with bare metal stents by serial intravascular ultrasound analyses: Data from the randomized TAXUS-II trial. Circulation 2004; 109: 196-200.
38. Fattori R, Piva T. Drug-eluting stents in vascular intervention. Lancet 2003; 361: 247-9.
39. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991; 5: 491-9.
40. Ishida M, Kato N, Hirano T, Suzuki T, Shomura Y, Yada I, Takeda K. Dissecting aneurysm of the superior mesenteric artery successfully treated by endovascular stent-graft placement. Cardiovasc Intervent Radiol 2003; 26: 403-6.
41. Kato M, Imanaka K, Kyo S, Ohuchi H, Asano H, Takamoto S. Successful treatment of ascending aortic graft infection after operation for acute aortic dissection with peripheral malperfusion. Ann Thorac Surg 2004; 77: 2194-5.
42. Stankovic G, Colombo A, Presbitero P, van den Branden F, Inglese L, Cernigliaro C, Niccoli L, Bartorelli AL, Rubartelli P, Reifart N, Heyndrickx GR, Saunamaki K, Morice MC, Sgura FA, Di Mario C. Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: The randomized evaluation of polytetrafluoroethylene covered stent in saphenous vein grafts (RECOVERS) Trial. Circulation 2003; 108: 37-42.
43. Gercken U, Lansky AJ, Buellesfeld L, Desai K, Badereldin M, Mueller R, Selbach G, Leon MB, Grube E. Results of the Jostent coronary stent graft implantation in various clinical settings: Procedural and follow-up results. Catheter Cardiovasc Interv 2002; 56: 353-60.
44. Nakayama Y, Nishi S, Ishibashi-Ueda H, Matsuda T. Surface microarchitectural design in biomedical applications: In vivo analysis of tissue ingrowth in excimer laser-directed micropored scaffold for cardiovascular tissue engineering. J Biomed Mater Res 2000; 51: 520-8.
45. Nakayama Y, Nishi S, Ueda-Ishibashi H, Matsuda T. Fabrication of micropored elastomeric film-covered stents and auto-phase performances. J Biomed Mater Res 2003, 64A: 52-61.
46. Nakayama Y, Nishi S, Ueda-Ishibashi H. Fabrication of drug-eluting covered stents with micropores and differential coating of heparin and FK506. Cardiovas Rad Med 2003 (in press).
47. Nishi S, Nakayama Y, Ishibashi-Ueda H, Matsuda T. Embolization of experimental aneurysms using a heparin-loaded stent graft with micropores. Cardiovasc Rad Med 2003; 4: 29-33.
48. De Scheerder I, Verbeken E, Van Humbeeck J. Metallic surface modification. Semin Interv Cardiol 1998; 3: 139-144.
49. Bar FW, van der Veen FH, Benzina A, Habets J, Koole LH. New biocompatible polymer surface coating for stents results in a low neointimal response. J Biomed Mater Res 2000; 52: 193-8.
50. Windecker S, Mayer I, De Pasquale G, Maier W, Dirsch O, De Groot P, Wu YP, Noll G, Leskosek B, Meier B, Hess OM. Working Group on Novel Surface Coating of Biomedical Devices (SCOL). Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation 2001; 104: 928-33.
51. Doi K, Matsuda T. Significance of porosity and compliance of microporous, polyurethane-based microarterial vessel on neoarterial wall regeneration. J Biomed Mater Res 1997; 37: 573-84.
52. Nakayama Y, Matsuda T. Surface microarchitectural design on biomedical applications: Preparation of microporous polymer surfaces by an excimer laser ablation technique. J Biomed Mater Res 1995; 29: 1295-301.
53. Liu J. FK506 and cyclosporin, molecular probes for studying intracellular signal transduction. Immuno Today 1993; 14: 290-5.
54. Fruman DA, Klee CB, Bierer BE, Burakoff SJ. Calcineurin phosphatase activity in T lymphocytes is inhibited by FK 506 and cyclosporin A. Proc Natl Acad Sci USA 1992; 89: 3686-90.
55. Fonarow GC, Watson KE. Effective strategies for long-term statin use. Am J Cardiol 2003; 92: 27i-34i.
56. Gomberg-Maitland M, Fuster V, Fayad ZA, Badimon JJ, Corti R. Statins and plaque stability. J Cardiovasc Risk 2003; 10: 161-7.