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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.
Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coroflex ISAR stent | Experimental | PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed. |
|
| Biomatrix stent | Active Comparator | PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymer-free stent | Device | PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCT-based intimal injury score | OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES | Up to 1 day (evaluated after stent implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue prolapse area | Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured | Up to 1 day (evaluated after stent implantation) |
| Incidence of stent malapposition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nieves Gonzalo, MD, PhD | Hospital Clinico San Carlos de Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | Spain | |||
| Hospital Clinico San Carlos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12096272 | Background | Sullivan TM, Ainsworth SD, Langan EM, Taylor S, Snyder B, Cull D, Youkey J, Laberge M. Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis. J Vasc Surg. 2002 Jul;36(1):143-9. doi: 10.1067/mva.2002.122878. | |
| 16650911 | Background | Hara H, Nakamura M, Palmaz JC, Schwartz RS. Role of stent design and coatings on restenosis and thrombosis. Adv Drug Deliv Rev. 2006 Jun 3;58(3):377-86. doi: 10.1016/j.addr.2006.01.022. Epub 2006 Mar 6. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Biodegradable-polymer stent | Device | PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix) |
|
|
Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT
| Up to 1 day (evaluated after stent implantation) |
| Incidence of stent underexpansion | Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix | Up to 1 day (evaluated after stent implantation) |
| Stent symmetry after implantation | Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix | Up to 1 day (evaluated after stent implantation) |
| Baseline plaque type | Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich) | Up to 1 day (evaluated after stent implantation) |
| Madrid |
| 28040 |
| Spain |
| Hospital Universitario de La Princesa | Madrid | Spain |
| 12081990 | Background | Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 Jun 25;105(25):2974-80. doi: 10.1161/01.cir.0000019071.72887.bd. |
| 7796511 | Background | Rogers C, Edelman ER. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 1995 Jun 15;91(12):2995-3001. doi: 10.1161/01.cir.91.12.2995. |
| 16733073 | Background | Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6. |
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| 24642998 | Background | Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18. |
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| 22730760 | Background | Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schomig A. [Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial]. Vestn Rentgenol Radiol. 2012 Mar-Apr;(2):52-60. Russian. |
| 12706922 | Background | Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Muller M, Dirschinger J, Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003 Apr 16;41(8):1283-8. doi: 10.1016/s0735-1097(03)00119-0. |
| 16814667 | Background | Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5. |
| 22535188 | Background | Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012 Jun;107(6):1161-71. doi: 10.1160/TH12-01-0043. Epub 2012 Apr 26. |
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| 26196753 | Background | Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53. |
| 26292590 | Background | Otsuka F, Cheng Q, Yahagi K, Acampado E, Sheehy A, Yazdani SK, Sakakura K, Euller K, Perkins LEL, Kolodgie FD, Virmani R, Joner M. Acute Thrombogenicity of a Durable Polymer Everolimus-Eluting Stent Relative to Contemporary Drug-Eluting Stents With Biodegradable Polymer Coatings Assessed Ex Vivo in a Swine Shunt Model. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1248-1260. doi: 10.1016/j.jcin.2015.03.029. |
| 25601953 | Background | Otsuka F, Yahagi K, Ladich E, Kutys R, Alexander R, Fowler D, Virmani R, Joner M. Hypersensitivity reaction in the US Food and Drug Administration-approved second-generation drug-eluting stents: histopathological assessment with ex vivo optical coherence tomography. Circulation. 2015 Jan 20;131(3):322-4. doi: 10.1161/CIRCULATIONAHA.114.012658. No abstract available. |
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| 25464257 | Background | Alfonso F, Sandoval J, Perez-Vizcayno MJ, Cardenas A, Gonzalo N, Jimenez-Quevedo P, Ibanez B, Nunez-Gil I, Rivero F, Escaned J, Fernandez-Ortiz A, Macaya C. Mechanisms of balloon angioplasty and repeat stenting in patients with drug-eluting in-stent restenosis. Int J Cardiol. 2015 Jan 15;178:213-20. doi: 10.1016/j.ijcard.2014.10.139. Epub 2014 Oct 23. |
| 19671534 | Background | Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E. Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach. Heart. 2009 Dec;95(23):1913-9. doi: 10.1136/hrt.2009.172072. Epub 2009 Aug 10. |
| 32826450 | Derived | Vilchez-Tschischke JP, Salazar C, Gil-Romero J, Mori R, Nunez-Gil I, Quiros A, Nombela L, Del Trigo M, Jimenez-Quevedo P, Salinas P, Escaned J, Macaya C, Gonzalo N. Stent strut thickness and acute vessel injury during percutaneous coronary interventions: an optical coherence tomography randomized clinical trial. Coron Artery Dis. 2021 Aug 1;32(5):382-390. doi: 10.1097/MCA.0000000000000943. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |