open access
The role of superficial wall stress and mechanical factors in scaffold failure: Protocol of the RANSOMED study


- Department of Cardiovascular Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- CardioCare Heart Center, Marbella, Spain
- Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
- First Cardiology Department, Gdansk University Hospital, Gdansk, Poland
- University Medical Center, Mainz, Germany, Mainz
open access
Abstract
Abstract


Title
The role of superficial wall stress and mechanical factors in scaffold failure: Protocol of the RANSOMED study
Journal
Issue
Article type
Study Protocol
Pages
319-323
Published online
2022-01-11
Page views
5109
Article views/downloads
567
DOI
10.5603/CJ.a2022.0001
Pubmed
Bibliographic record
Cardiol J 2022;29(2):319-323.
Authors
Juan Luis Gutiérrez-Chico
Lili Liu
Miao Chu
Ruiyan Zhang
Milosz J. Jaguszewski
Giulio Makmur
Tommaso Gori
Shengxian Tu


- Wykrzykowska JJ, Onuma Y, Serruys PW. Vascular restoration therapy: the fourth revolution in interventional cardiology and the ultimate "rosy" prophecy. EuroIntervention. 2009; 5 Suppl F: F7–F8.
- Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009; 373(9667): 897–910.
- Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008; 371(9616): 899–907.
- Onuma Y, Serruys PW, Ormiston JA, et al. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010; 6(4): 447–453.
- Dudek D, Onuma Y, Ormiston JA, et al. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012; 7(9): 1060–1061.
- Onuma Y, Dudek D, Thuesen L, et al. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013; 6(10): 999–1009.
- Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015; 10(10): 1144–1153.
- Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015; 385(9962): 43–54.
- Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016; 388(10059): 2479–2491.
- Wykrzykowska J, Kraak R, Hofma S, et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017; 376(24): 2319–2328.
- Serruys PW, Onuma Y, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011; 58(15): 1578–1588.
- Puricel S, Cuculi F, Weissner M, et al. Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol. 2016; 67(8): 921–931.
- Gutiérrez-Chico JL, Cortés C, Schincariol M, et al. Implantation of bioresorbable scaffolds under guidance of optical coherence tomography: Feasibility and pilot clinical results of a systematic protocol. Cardiol J. 2018; 25(4): 443–458.
- Räber L, Brugaletta S, Yamaji K, et al. Very late scaffold thrombosis: intracoronary imaging and histopathological and Spectroscopic findings. J Am Coll Cardiol. 2015; 66(17): 1901–1914.
- Onuma Y, Serruys PW, Perkins LEL, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation. 2010; 122(22): 2288–2300.
- Aoki J, Nakazawa G, Tanabe K, et al. Incidence and clinical impact of coronary stent fracture after sirolimus-eluting stent implantation. Catheter Cardiovasc Interv. 2007; 69(3): 380–386.
- Lee MS, Jurewitz D, Aragon J, et al. Stent fracture associated with drug-eluting stents: clinical characteristics and implications. Catheter Cardiovasc Interv. 2007; 69(3): 387–394.
- Kuramitsu S, Hiromasa T, Enomoto S, et al. Incidence and clinical impact of stent fracture after everolimus-eluting stent implantation. Circ Cardiovasc Interv. 2012; 5(5): 663–671.
- Wu X, von Birgelen C, Muramatsu T, et al. A novel four-dimensional angiographic approach to assess dynamic superficial wall stress of coronary arteries in vivo: initial experience in evaluating vessel sites with subsequent plaque rupture. EuroIntervention. 2017; 13(9): e1099–e1103.
- Wu X, von Birgelen C, Li Z, et al. Assessment of superficial coronary vessel wall deformation and stress: validation of in silico models and human coronary arteries in vivo. Int J Cardiovasc Imaging. 2018; 34(6): 849–861.
- Gutiérrez-Chico JL. Superficial wall stress: the long awaited comprehensive biomechanical parameter to objectify and quantify our intuition. Int J Cardiovasc Imaging. 2018; 34(6): 863–865.