CLINICAL

CeloNova Clinical Trials

The PzF SHIELD Trial

This is a prospective, multi-center, non-randomized, single arm clinical trial that was conducted at 35 sites in the United States and Outside United States (OUS). This study is a US FDA approved trial for the COBRA PzF stent.

CeloNova plans on announcing the primary endpoint results at TCT 2016.

TCT 2016 Symposium

COBRA REDUCE Trial

About one in five patients are at high risk of bleeding after stenting. Complications from bleeding after PCI occur more frequently than myocardial infarctions and have a greater impact on mortality.1 This randomized controlled trial will evaluate if the COBRA PzF stent, with its novel Polyzene-F nanocoating and advanced thin-strut design, can help reduce bleeding as compared to drug eluting stents (DES), by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing PCI.

For additional trial information, please visit clinicaltrials.gov.

1 Genereux, et al. JACC 2015;66:1036-45.

Publications

CeloNova BioScience’s first and second generation coronary stents with novel Polyzene-F nanocoating have been studied in numerous peer reviewed journals. Learn more in our publications below:

Cutlip DE, Garratt KN, Novack V, et. al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017 Jan 23;10(2):160-167.
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Tamburino C, La Manna A, Di Salvo ME, et al.  First-in-man 1-year clinical outcomes of the CATANIA Coronary Stent System with Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The Latest Non-Thrombogenic Angioplasty stent) Trial. JACC Cardiovascular Interventions. 2009; 2:197-204.
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Tamburino C, Capodanno D, Di Salvo ME, et al.  Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry. EuroIntervention. 2012; 7:1062-1068.
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La Manna A, Capodanno D, Cera M, Di Salvo ME, et al. Optical Coherence Tomographic Results at Six-Month Follow-Up Evaluation of the CATANIA Coronary Stent System with NanoThin Polyzene-F Surface Modification (from the Assessment of the Latest Non-Thrombogenic Angioplasty Stent [ATLANTA] Trial). American Journal of Cardiology. 2009; 103:1551-1555.
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Tamburino C, Giacoppo D, Capodanno D. The Rapid Evaluation of Vessel Healing after Angioplasty (REVEAL) trial. Interventional Cardiology. 2011; 3:451-460.
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Sakakura K, Pacheco E, Nakano M, et al. Improved arterial healing in response to a novel polyphosphazene surface-modified stent in swine. EuroIntervention. May 22, 2013.
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Wade CWR, Gourlay S, Rice R, Hegyeli A, et al. Biocompatibility of Eight Poly(Organophosphazenes). US Army Medical Bioengineering Research & Development Laboratory and Army Material and Mechanics Research Center.

Richter GM, Stampfl U, Stampfl S, Rehnitz C, et al.  A New Polymer Concept for Coating of Vascular Stents Using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to Reduce Thrombogenicity and Late In-Stent Stenosis. Investigative Radiology. 2005; 40:210-8.
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Satzl S, Henn C, Christoph P, et al.  The Efficacy of Nanoscale Poly[bis(triflouroethoxy)phosphazene] (PTFEP) Coatings in Reducing Thrombogenicity and Late In-Stent Stenosis in a Porcine Coronary Artery Model. Investigative Radiology. 2007; 42:303-11.
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Radeleff B, Thierjung H, Stampfl U, et al. Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. CardioVascular and Interventional Radiology. 2008; 31:971-80.
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Stampfl U, Sommer C, Thierjung H, et al. Reduction of Late In-Stent Stenosis in a Porcine Coronary Artery Model by Cobalt Chromium Stents with a Nanocoat of Polyphosphazene (Polyzene-F ). CardioVascular and Interventional Radiology. 2008; August 15.
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Henn C, Satzl S, Christoph P, et al. Efficacy of a Plyphosphazene Nanocoat in reducing Thrombogenicity, In-Stent Stenosis, and Inflammatory Response in Porcine Renal and Iliac Artery Stents. Journal of Vascular and Interventional Radiology. 2008;19:427-37.
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Welle A, Grunze M, Tur D. Plasma Protein Adsorption and Platelet Adhesion on Poly[bis(trifluoroethoxy)phosphazene] and reference material surfaces. Journal of Colloid and Interface Science. 1998; 197:263-274.
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Reichert WM, Filisko FE, Barenberg SA. Polyphosphazenes: Effect of molecular motions on thrombogenesis. Journal of Biomedical Materials Research. 1982; 16:301-312.
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Huang Y, Liu X, Wang L, et al. Long-term biocompatibility evaluation of a novel polymer-coated stent in a porcine coronary stent model. Coronary Artery Disease. 2003; 14:401-408.
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Welle A, Grunze M, Tur D. Blood Compatibility of Poly[bis(trifluoroethoxy)phosphazene]. Journal of Applied Medical Polymers. 2000; 4:6-10.
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Mrowietz C, Franke RP, Seyfert UT, et al. Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clinical Hemorheology and Microcirculation. 2005; 32(2):89-103.
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