Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)
To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcificatition by opticaL COHERENCE TOMOGRAPHY.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience Skypoint stent over calcified coronary lesions | Device | Patients with Xience Skypoint stent implanted after OCT assesment of calcification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean strut coverage thickness of stent | Mean strut coverage thickness (μ) of the stent struts located over superficial calcium will be compared to the mean strut coverage thickness of the struts in the calcium free frames by Optical Coherence Tomography (OCT). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of covered struts | proportion of covered struts (%) lying over superficial calcium compared to the proportion of covered struts in calcium free frames | 1 month |
| Proportion of uncovered struts |
Not provided
Inclusion Criteria:
Patients who meet all the following conditions will be included:
Exclusion Criteria:
Patients who meet, at least, 1 of the following conditions will be excluded:
Patients with current ST-elevation Myocardial Infarction (STEMI).
Patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts.
Patients with contraindication for the 1-month follow-up angiography and OCT:
Patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BRUNO GARCIA DEL BLANCO, MD, PhD | Contact | 0034932746155 | brunogb51@gmail.com | |
| FUNDACION EPIC | Contact | 00987876135 | iepic@fundacionepic.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall Hebron | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24561145 | Background | Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19. | |
| 16326375 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proportion of uncovered struts by OCT at 1 month comparing calcified and non-calcified struts by OCT
| 1 month |
| Proportion of acute post PCI malapposition struts | Proportion of acute post PCI malapposition comparing calcified and non-calcified struts by OCT | 1 month |
| Proportion of malapposed struts | Proportion of malapposed struts comparing calcified and non-calcified struts by OCT at 1 month | 1 month |
| Proportion of the resolution of the baseline malapposition struts | Proportion of the resolution of the baseline malapposition struts according to the presence of underlying superficial calcium by OCT at 1 month | 1 month |
| Degree of endothelialization | Difference in mean struck coverage thickness between calcified lesion and no calcified lesion | 1 month |
| Major adverse cardiovascular events (MACE) | Major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, cardiac death, myocardial infarction, or target vessel revascularization at 6 months | 6 months |
| All Death | Freedom from all Death | 6 months |
| Cardiac Death | Freedom from Cardiac Death | 6 months |
| Myocardial Infarction | Freedom from Myocardial Infarction | 6 months |
| Target Vessel Revascularization | Freedom from Target Vessel Revascularization | 6 months |
| Background |
| Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005 Oct-Dec;6(4):147-53. doi: 10.1016/j.carrev.2005.08.008. |
| 23995714 | Background | Lindsay AC, Paulo M, Kadriye K, Tejeiro R, Alegria-Barrero E, Chan PH, Foin N, Syrseloudis D, Di Mario C. Predictors of stent strut malapposition in calcified vessels using frequency-domain optical coherence tomography. J Invasive Cardiol. 2013 Sep;25(9):429-34. |
| 24906449 | Background | Honda Y, Toyama T, Miyaishi Y, Kan H, Kawaguchi R, Adachi H, Hoshizaki H, Oshima S. Coronary artery calcification as a new predictor of non-target lesion revascularization during the chronic phase after successful percutaneous coronary intervention. Cardiovasc Interv Ther. 2014 Oct;29(4):315-23. doi: 10.1007/s12928-014-0274-4. Epub 2014 Jun 7. |
| 24530667 | Background | Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12. |
| 35472561 | Background | Otaegui Irurueta I, Gonzalez Sucarrats S, Barron Molina JL, Perez de Prado A, Massotti M, Carmona Ramirez MA, Marti G, Bellera N, Serra B, Serra V, Domingo E, Lopez-Benito M, Sabate M, Ferreira Gonzalez I, Garcia Del Blanco B. Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent. Int J Cardiol. 2022 Aug 1;360:13-20. doi: 10.1016/j.ijcard.2022.04.043. Epub 2022 Apr 25. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |