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Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated Balloon (DCB) | Active Comparator | Drug Coated Balloon (DCB) |
|
| Drug Eluting Stent (DES) | Experimental | Drug Eluting Stent (DES) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Coated Balloon (DCB) | Device | Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L). | Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L). | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of percentage of angiographic restenosis by quantitative coronary | Comparison of percentage of angiographic restenosis by quantitative coronary | 8 months |
| Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography |
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Inclusion Criteria:
Patients who meet all of the following conditions are included.
Exclusion Criteria:
Patients who meet at least one of the following conditions are excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD | Contact | 0034630901145 | inigo.lozano@fundacionepic.org | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain | ||
| Hospital Universitario de Cabueñes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32138967 | Background | Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. | |
| 21349465 | Background | Nakamura T, Brott BC, Brants I, Panchal D, Li J, Chen JP, King SB 3rd, Chronos N, Hou D. Vasomotor function after paclitaxel-coated balloon post-dilation in porcine coronary stent model. JACC Cardiovasc Interv. 2011 Feb;4(2):247-55. doi: 10.1016/j.jcin.2010.08.028. |
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| Drug Eluting Stent (DES) | Device | Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI) |
|
Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography |
| 8 months |
| Comparison of the minimum luminal area of the treated segment by optical coronary tomography | Comparison of the minimum luminal area of the treated segment by optical coronary tomography | 8 months |
| Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group | Percentage of of strut coverage by OCT in the DES group | 8 months |
| Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months | Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months | 8 months |
| Recruiting |
| Gijón |
| 33394 |
| Spain |
| Hospital Universitario Juan Ramón Jiménez | Recruiting | Huelva | 21005 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 24008 | Spain |
| Hospital Universitario Lucus Augusti | Recruiting | Lugo | 270003 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
| Hospital Provincial de Pontevedra | Recruiting | Pontevedra | 36071 | Spain |
| Background | Gutierrez E G-LJ, Escaned J, Cruz I, Ojeda S, Romaguera R, Moreno R. Valoración de la función endotelial y provocación de vasoespasmo coronario mediante infusión intracoronaria de acetilcolina. Documento técnico de la ACI-SEC. REC Interv Cardiol. 2021;3(4):286-296. |
| 34729992 | Background | Gomez-Lara J, Oyarzabal L, Ortega-Paz L, Brugaletta S, Romaguera R, Salvatella N, Roura G, Rivero F, Fuentes L, Alfonso F, Otaegui I, Vandeloo B, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation. J Am Heart Assoc. 2021 Nov 16;10(22):e022123. doi: 10.1161/JAHA.121.022123. Epub 2021 Nov 3. |
| 22507972 | Background | Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J. 2012 Jun;33(11):1325-33. doi: 10.1093/eurheartj/ehr466. Epub 2012 Apr 16. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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