PzF SHIELD is a single-arm, non-randomized, prospective clinical trial that met its primary endpoint of TVF and the secondary endpoint of angiographic late lumen loss at 270 days.
Stent Thrombosis2
TLR2
Month DAPT3
minimum requirement
Stent Thrombosis2
TLR2
Month DAPT3
minimum requirement
eCOBRA is a prospective, consecutively enrolled, observational, multi-center, all-comers study that demonstrated positive outcomes in patients at high risk of bleeding and stent thrombosis in a real-world setting.
Late Stent Thrombosis4 (Definite/Probable)
TLR4
High Risk Patients4
CeloNova BioSciences’ comprehensive clinical program consists of approximately 3,300 patients worldwide, including over 2,400 being evaluated with the 2nd generation PzF NanoCoated stent, COBRA PzF NCS.
COBRA REDUCE is the world’s first and only randomized, global study designed to assess clinical outcomes in high bleeding risk patients with COBRA PzF NCS and 14-Day DAPT compared to FDA-Approved DES with 3 or 6-months of DAPT.§
Enrollment status: Complete
For additional information visit clinicaltrials.gov/NCT02594501
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 the publications below:
Luc Maillard et. al.
Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high‐risk patients: The e‐Cobra study. Catheterization and Cardiovascular Interventions. June 17, 2020.
Mark C. Bates, et. al.
Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating. Regenerative Engineering and Translational Medicine. March 14, 2019.
Mori H., Jinnouchi H., et. al.
A new category stent with novel polyphosphazene surface modification. Future Cardiology (Epub ahead of print). Published Online: 27 Mar 2018 https://doi.org/10.2217/fca-2017-0103
Styllou P, Silber S.
A case report of the new Polyzene™-F COBRA PzF™ Nanocoated Coronary Stent System (NCS): Addressing an unmet clinical need. Cardiovascular Revascularization Medicine. 2016 April-May;17(3):209-211.
Cutlip DE, Garratt KN, Novack V, et. al
9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovascular Interventions. 2017 Jan 23;10(2):160-167.
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.
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.
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.
Tamburino C, Giacoppo D, Capodanno D.
The Rapid Evaluation of Vessel Healing after Angioplasty (REVEAL) trial. Interventional Cardiology. 2011; 3:451-460.
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.
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.
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.
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.
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.
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.
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.
Reichert WM, Filisko FE, Barenberg SA.
Polyphosphazenes: Effect of molecular motions on thrombogenesis. Journal of Biomedical Materials Research. 1982; 16:301-312.
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.
Welle A, Grunze M, Tur D.
Blood Compatibility of Poly[bis(trifluoroethoxy)phosphazene]. Journal of Applied Medical Polymers. 2000; 4:6-10.
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.
