Experimental evaluation of pharmacokinetic profile and biological effect of a novel paclitaxel microcrystalline balloon coating in the iliofemoral territory of swine

Catheterization and Cardiovascular Interventions

Volumn 83, Issue 2, 2014, Pages 325-333

  Buszman, Piotr P ^a,b   Milewski, Krzysztof ^a   Zurakowski, Aleksander ^a   Pajak, Jacek ^c   Jelonek, Michał ^a   Gasior, Paweł ^a,c   Peppas, Athanasios ^b   Tellez, Armando ^b   Granada, Juan F ^b   Buszman, Paweł E ^a  

^a American Heart of Poland Inc   (Poland)

^b CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

^c MEDICAL UNIVERSITY OF SILESIA   (Poland)

Author keywords

drug delivery; paclitaxel coated balloon; peripheral vascular disease; restenosis

Indexed keywords

FIBRIN; PACLITAXEL; PAX; UNCLASSIFIED DRUG;

ANGIOGRAPHY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTERY OCCLUSION; ARTICLE; BALLOON CATHETER; BIOLOGICAL ACTIVITY; CONTROLLED STUDY; CRYSTAL; DRUG DELIVERY SYSTEM; ENDOTHELIALIZATION; EPITHELIZATION; FEMALE; FEMORAL ARTERY; HEALING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HISTOPATHOLOGY; ILIOFEMORAL ARTERY; INFLAMMATION; INTERMETHOD COMPARISON; MALE; MINERALIZATION; NEOINTIMA; NEOINTIMAL HYPERPLASIA; NONHUMAN; PACLITAXEL COATED BALLOON; SCORING SYSTEM; SELF-EXPANDIBLE STENT; STENT; SWINE;

DRUG DELIVERY; PACLITAXEL COATED BALLOON; PERIPHERAL VASCULAR DISEASE; RESTENOSIS;

ANGIOPLASTY, BALLOON; ANIMALS; CARDIOVASCULAR AGENTS; CELL PROLIFERATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; COATED MATERIALS, BIOCOMPATIBLE; CRYSTALLIZATION; DRUG-ELUTING STENTS; FEMALE; FEMORAL ARTERY; HYPERPLASIA; ILIAC ARTERY; MALE; MATERIALS TESTING; MODELS, ANIMAL; NEOINTIMA; PACLITAXEL; PROSTHESIS DESIGN; SUS SCROFA; WOUND HEALING;

EID: 84892806855     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.24982     Document Type: Article

References (19)

1. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U,. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006; 355: 2113-2124.
2. Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B,. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 2009; 119: 2986-2994.
3. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U,. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008; 358: 689-699.
4. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J,. Inhibition of restenosis in femoropopliteal arteries: Paclitaxel-coated versus uncoated balloon: Femoral paclitaxel randomized pilot trial. Circulation 2008; 118: 1358-1365.
5. Stella PR, Belkacemi A, Dubois C, Nathoe H, Dens J, Naber C, Adriaenssens T, van Belle E, Doevendans P, Agostoni P,. A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv 2012; 80: 1138-1146.
6. Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U,. Paclitaxel-coated balloon versus drug-eluting stent during pci of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart 2010; 96: 1291-1296.
7. Woehrle J, Motz W, Moebius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon J-P, Cassel G, Elbal L, Scheller B,. Sequent please worl wide registry: Results of paclitaxel coated balloon angioplasty for treatment of de-novo coronary artery disease. J Am Coll Cardiol 2012; 59: E57.
8. Hamm C,. Paclitaxel-eluting ptca-balloon in combination with the cloroflex blue stent vs. The sirolimus coated cypher stent in the treatment of advanced coronary artery disease. American Heart Association Scientific Sessions 2009; November 14, 2009; Orlando, FL. 2009.
9. Institute of Laboratory Animal Resources NRC. Principles of care of laboratory animals. NIH Publication; 1996. pp 85-23.
10. Schwartz RS, Huber KC, Murphy JG, Edwards WD, Camrud AR, Vlietstra RE, Holmes DR,. Restenosis and the proportional neointimal response to coronary artery injury: Results in a porcine model. J Am Coll Cardiol 1992; 19: 267-274.
11. Kornowski R, Hong MK, Tio FO, Bramwell O, Wu H, Leon MB,. In-stent restenosis: Contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol 1998; 31: 224-230.
12. Schwartz RS, Edelman E, Virmani R, Carter A, Granada JF, Kaluza GL, Chronos NA, Robinson KA, Waksman R, Weinberger J, Wilson GJ, Wilensky RL,. Drug-eluting stents in preclinical studies: Updated consensus recommendations for preclinical evaluation. Circ Cardiovasc Int 2008; 1: 143-153.
13. Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B,. Paclitaxel-coated balloons-survey of preclinical data. Minerva Cardioangiol 2010; 58: 567-582.
14. Granada JF, Milewski K, Zhao H, Stankus JJ, Tellez A, Aboodi MS, Kaluza GL, Krueger CG, Virmani R, Schwartz LB, Nikanorov A,. Vascular response to zotarolimus-coated balloons in injured superficial femoral arteries of the familial hypercholesterolemic swine. Circ Cardiovasc Int 2011; 4: 447-455.
15. Milewski K, Tellez A, Aboodi MS, Conditt GB, Yi GH, Thim T, Stenoien M, McGregor JC, Gray WA, Virmani R, Granada JF, Kaluza GL,. Paclitaxel-iopromide coated balloon followed by "bail-out" bare metal stent in porcine iliofemoral arteries: First report on biological effects in peripheral circulation. EuroIntervention 2011; 7: 362-368.
16. Speck U, Cremers B, Kelsch B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, Hanisch U, Bohm M, Scheller B,. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? Circ Cardiovasc Int 2012; 5: 392-400.
17. Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D, Gyongyosi M,. Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries. Coron Artery Dis 2008; 19: 243-247.
18. Stella PR, Belkacemi A, Waksman R, Stahnke S, Torguson R, von Strandmann RP, Agostoni P, Sangiorgi G, Silber S,. The valentines trial: Results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation dior paclitaxel drug-eluting balloon for in-stent restenosis treatment. EuroIntervention 2011; 7: 705-710.
19. Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G,. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 2004; 110: 810-814.