Cargando…

Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial

INTRODUCTION: To assess the impact of ‘reverse T and Protrusion’ (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. METHODS AND ANALYSIS: 50 consecutive patients with tru...

Descripción completa

Detalles Bibliográficos
Autores principales: Rakhimov, Kudrat, Buono, Andrea, Anadol, Remzi, Ullrich, Helen, Knorr, Maike, Ahoopai, Majid, Münzel, Thomas, Gori, Tommaso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304799/
https://www.ncbi.nlm.nih.gov/pubmed/32554736
http://dx.doi.org/10.1136/bmjopen-2019-034264
_version_ 1783548330830200832
author Rakhimov, Kudrat
Buono, Andrea
Anadol, Remzi
Ullrich, Helen
Knorr, Maike
Ahoopai, Majid
Münzel, Thomas
Gori, Tommaso
author_facet Rakhimov, Kudrat
Buono, Andrea
Anadol, Remzi
Ullrich, Helen
Knorr, Maike
Ahoopai, Majid
Münzel, Thomas
Gori, Tommaso
author_sort Rakhimov, Kudrat
collection PubMed
description INTRODUCTION: To assess the impact of ‘reverse T and Protrusion’ (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. METHODS AND ANALYSIS: 50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient’s discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned. ETHICS AND DISSEMINATION: The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03714750)
format Online
Article
Text
id pubmed-7304799
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-73047992020-06-22 Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial Rakhimov, Kudrat Buono, Andrea Anadol, Remzi Ullrich, Helen Knorr, Maike Ahoopai, Majid Münzel, Thomas Gori, Tommaso BMJ Open Cardiovascular Medicine INTRODUCTION: To assess the impact of ‘reverse T and Protrusion’ (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique. METHODS AND ANALYSIS: 50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient’s discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned. ETHICS AND DISSEMINATION: The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03714750) BMJ Publishing Group 2020-06-16 /pmc/articles/PMC7304799/ /pubmed/32554736 http://dx.doi.org/10.1136/bmjopen-2019-034264 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Cardiovascular Medicine
Rakhimov, Kudrat
Buono, Andrea
Anadol, Remzi
Ullrich, Helen
Knorr, Maike
Ahoopai, Majid
Münzel, Thomas
Gori, Tommaso
Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title_full Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title_fullStr Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title_full_unstemmed Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title_short Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
title_sort randomised, non-inferiority, controlled procedural outcomes trial comparing reverse t and protrusion versus double-kissing and crush stenting: protocol of the tip tap i randomised trial
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304799/
https://www.ncbi.nlm.nih.gov/pubmed/32554736
http://dx.doi.org/10.1136/bmjopen-2019-034264
work_keys_str_mv AT rakhimovkudrat randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT buonoandrea randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT anadolremzi randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT ullrichhelen randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT knorrmaike randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT ahoopaimajid randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT munzelthomas randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial
AT goritommaso randomisednoninferioritycontrolledproceduraloutcomestrialcomparingreversetandprotrusionversusdoublekissingandcrushstentingprotocolofthetiptapirandomisedtrial