Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries (TRYTON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01258972|
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : October 18, 2016
Tryton Medical, Inc.
Information provided by (Responsible Party):
Tryton Medical, Inc.
Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
|Recruitment Status :||Completed|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||October 2016|
|Submission Cycle||Results Submitted to ClinicalTrials.gov||Results Returned after Quality Control Review|
|1||September 29, 2017|
|2||October 2, 2017|
|3||October 18, 2017||November 21, 2017|
|4||February 23, 2018||March 23, 2018|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Muramatsu T, Grundeken MJ, Ishibashi Y, Nakatani S, Girasis C, Campos CM, Morel MA, Jonker H, de Winter RJ, Wykrzykowska JJ, García-García HM, Leon MB, Serruys PW, Onuma Y; TRYTON Pivotal IDE Coronary Bifurcation Trial Investigators. Comparison between two- and three-dimensional quantitative coronary angiography bifurcation analyses for the assessment of bifurcation lesions: A subanalysis of the TRYTON pivotal IDE coronary bifurcation trial. Catheter Cardiovasc Interv. 2015 Sep;86(3):E140-9. doi: 10.1002/ccd.25925. Epub 2015 Apr 24.
Grundeken MJ, Ishibashi Y, Généreux P, LaSalle L, Iqbal J, Wykrzykowska JJ, Morel MA, Tijssen JG, de Winter RJ, Girasis C, Garcia-Garcia HM, Onuma Y, Leon MB, Serruys PW. Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: a post-hoc analysis of a randomized trial. JACC Cardiovasc Interv. 2015 Feb;8(2):305-314. doi: 10.1016/j.jcin.2014.12.002.
Généreux P, Kumsars I, Lesiak M, Kini A, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefèvre T, Feldman RL, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, Leon MB. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. J Am Coll Cardiol. 2015 Feb 17;65(6):533-43. doi: 10.1016/j.jacc.2014.11.031.