The ProLimus trial: A prospective, non-randomised, multicentre trial to evaluate the safety and clinical performance of the pimecrolimus eluting stent system (ProGenic)

EuroIntervention

Volumn 5, Issue 2, 2009, Pages 233-238

  Verheye, Stefan ^a   Sarno, Giovana ^b   Müller, Ralf ^c   Birkemeyer, Ralf ^d   Vrints, Christiaan ^e   Jung, Werner ^d   Agostoni, Pierfrancesco ^f   van Langenhove, Glenn ^a   Haine, Steven ^e   Willems, Tine ^f   Haude, Michael ^g   Grube, Eberhard ^c   Wijns, William ^b  

^a MIDDELHEIM HOSPITAL   (Belgium)

^b CARDIOVASCULAR CENTER   (Belgium)

^c Heart Center Siegburg   (Germany)

^d Schwarzwald Baar Klinikum Villingen Schwenningen   (Germany)

^e ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^f Genae Associates nv   (Belgium)

^g Stadtische Kliniken Neuss   (Germany)

Author keywords

Drug eluting stent; PCI; Pimecrolimus

Indexed keywords

CHROMIUM; COBALT; PIMECROLIMUS; POLYLACTIC ACID;

AGED; ANGIOCARDIOGRAPHY; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ELUTING STENT; FEMALE; HUMAN; IN-STENT RESTENOSIS; INTRAVASCULAR ULTRASOUND; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; STENT THROMBOSIS;

EID: 77953663659     PISSN: 1774024X     EISSN: None     Source Type: Journal    
DOI: 10.4244/EIJV5I2A36     Document Type: Article

References (18)

1. Bhatia V, Bhatia R, Dhinsda M. Drug-eluting stents: new era and new concerns. Postgrad Med J. 2004;80:13-8.
2. Marx SO, Marks AR. Bench to bedside: the development of rapamycin and its application to stent restenosis. Circulation. 2001;104:852-5.
3. Bolz A, Amon M, Ozbek C, Heublein B, Schaldach M. Coating of cardiovascular stents with a semiconductor to improve their hemocompatibility. Tex Heart Inst J. 1996;23:162-6.
4. Monnink SH, van Boven AJ, Peels HO. Silicon-carbide coated coronary stents have low platelet and leukocyte adhesion during platelet activation. J Investig Med. 1999;47:304-10.
5. Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T, Okada M, Nakamura T, Komori H, Motohara S, Uehata H. Biodegradable Polymeric Stents. Curr Interv Cardiol Rep. 2001;3:10-7.
6. Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008;37:873-4.
7. Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9TM eluting stent with a biodegradable polymer coating. EuroIntervention 2005;1:53-7.
8. Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D, for the Nobori 1 Clinical Investigators Randomised comparison of Nobori™, biolimus A9-eluting coronary stent with a Taxus®, paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention 2007;2:426-34.
9. Waksman R, Pakala R, Baffour R, Hellinga D, Seabron R, Tio FO, Wittchow E, Tittelbach M, Diener T, Harder C, Virmani R, Jones R. Efficacy and safety of pimecrolimus-eluting stents in porcine coronary arteries. Cardiovasc Revasc Med. 2007;8:259-74.
10. Gupta AK, Chow M. Pimecrolimus: a review. J Eur Acad Dermatol Venereol. 2003;17:493-503.
11. Meingassner JG, Aschauer H, Stuetz A, Billich A. Pimecrolimus permeates less than tacrolimus through normal, inflamed, or corticosteroid-pretreated skin. Exp Dermatol. 2005;14:752-7.
12. Fajadet J, Wijns W, Laarman GJ, Kuch KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114:798-806.
13. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME TAXUS I: six- and twele-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003;107:38-42.
14. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-23.
15. Serruys PW, Ong ATL, FRACP, Piek JJ, Neuman FJ, Van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Therlouw PC. A randomized comparison of a durable polymer Everolimus eluting stent with a bare-metal coronary stent: The Spirit First Trial. EuroIntervention 2005;1:58-65.
16. Ormiston J, Webster MW, Gladding P, Stewart JT, Ruygrok PN, Hattrick R, Kay P. Outcome after pimecrolimus-Elution from a Durable Polymer on a stainless Steel Stent. First-in-Human Study Discordance with Preclinical Studies. Myocardial Ischemia and Infarction. J Am Coll Cardil. 2008;51(10 Suppl A):A178-A235.
17. Wang TY, Hasselblad V, Peterson JL, Wijns W, Parhizgar A, Kereiakes DJ, Krucoff MW. The Cobalt chromium Stent with Antiproliferative for Restenosis II (COSTAR II) trial study design: advancing the active-control evaluation of second-generation drug-eluting stents. Am Heart J. 2007;153:743-8.
18. Dawkins KD, Verheye S, Dens J, Rutsch W, Carrier D, Lotan C, Dubois C, Lansky A, Gambone L, Hacker. A Randomized Multi-center Study of the Pimecrolimus-eluting and Paclitaxel-eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries: GENESIS Trial 6 Month Results. PCI Coronary. J Am Coll Cardiol. 2008; 51(10 Suppl B):B1-B16.