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| Name | Class |
|---|---|
| Hospital Universitario Infanta Cristina de Badajoz | UNKNOWN |
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions.
This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel DES in the main branch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-eluting balloon | Experimental | Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun) |
|
| Paclitaxel-eluting stent | Experimental | Paclitaxel-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon angioplasty | Procedure | Coronary angioplasty using the paclitaxel-coated balloon catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss (LLL) | Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months | Late angiographic follow-up (9 months) |
| Restenosis | Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months | Late angiographic follow-up (9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis rate | Assesment of the thrombosis rate | Late angiographic follow-up (9 months) |
| Target Lesion Revascularization (TLR) | Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina |
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Inclusion Criteria:
PATIENTS
LESIONS
Exclusion Criteria:
PATIENTS
LESIONS
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| Name | Affiliation | Role |
|---|---|---|
| Jose Ramon Lopez-Minguez, MD, PhD | Hospital Universitario Infanta Cristina de Badajoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Cristina | Badajoz | Badajoz | 06080 | Spain | ||
| Hospital Universitari Son Dureta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16226167 | Background | Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28. | |
| 10700058 | Background | Lefevre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piechaud JF. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-n. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Stent implantation | Procedure | Coronary angioplasty using the paclitaxel-eluting stent |
|
|
| Late angiographic follow-up (9 months) |
| Major Adverse Cardiac Events (MACE) | Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis- | Late angiographic follow-up (9 months) |
| Palma de Mallorca |
| Balearic Islands |
| 07014 |
| Spain |
| Complejo Hospitalario San Pedro de Alcantara | Cáceres | Caceres | 10001 | Spain |
| Hospital Universitario Puerta del Mar | Cadiz | Cadiz | 11009 | Spain |
| Hospital Universitario de Puerto Real | Puerto Real | Cadiz | 11510 | Spain |
| Hospital Clinico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
| Hospital Virgen de la Salud | Toledo | Toledo | 45004 | Spain |
| 16098427 | Background | Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. doi: 10.1016/j.jacc.2005.04.054. |
| 10758954 | Background | Yamashita T, Nishida T, Adamian MG, Briguori C, Vaghetti M, Corvaja N, Albiero R, Finci L, Di Mario C, Tobis JM, Colombo A. Bifurcation lesions: two stents versus one stent--immediate and follow-up results. J Am Coll Cardiol. 2000 Apr;35(5):1145-51. doi: 10.1016/s0735-1097(00)00534-9. |
| 14981005 | Background | Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23. |
| 15523318 | Background | Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64. doi: 10.1016/j.ahj.2004.05.029. |
| 17060387 | Background | Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23. |
| Background | Hildick-Smith D, The BBC ONE (British Bifurcation Coronary study: Old, New and Evolving strategies). Transcatheter Cardiovascular Therapeutics 2008; Oct 12-17. 2008. Washington DC. TCT 2008 |
| 16324581 | Background | Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernandez-Duenas J, Herrador J, Urena I. [Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. Rev Esp Cardiol. 2005 Nov;58(11):1278-86. Spanish. |
| Background | Suárez de Lezo J, Medina A, Martín P, Amador C, Delgado A, Suárez de Lezo J et al. Hallazgos ultrasónicos durante el tratamiento percutáneo de lesiones coronarias en bifurcaciones. Rev Esp Cardiol 2008;61:930-5 |
| 16540043 | Background | Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish. |
| 16996856 | Background | Dzavik V, Kharbanda R, Ivanov J, Ing DJ, Bui S, Mackie K, Ramsamujh R, Barolet A, Schwartz L, Seidelin PH. Predictors of long-term outcome after crush stenting of coronary bifurcation lesions: importance of the bifurcation angle. Am Heart J. 2006 Oct;152(4):762-9. doi: 10.1016/j.ahj.2006.04.033. |
| 15963413 | Background | Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005 Jun 21;45(12):2088-92. doi: 10.1016/j.jacc.2005.02.086. |
| 15870416 | Background | Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126. |
| 14563585 | Background | Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8. |
| 15302790 | Background | Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9. |
| 9244237 | Background | Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A, Wild DH, Brehm BR, Riessen R, Koveker G, Karsch KR. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997 Jul 15;96(2):636-45. doi: 10.1161/01.cir.96.2.636. |
| 18480668 | Background | Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D, Gyongyosi M. Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries. Coron Artery Dis. 2008 Jun;19(4):243-7. doi: 10.1097/MCA.0b013e3283030b26. |
| 8782834 | Background | Nikol S, Huehns TY, Hofling B. Molecular biology and post-angioplasty restenosis. Atherosclerosis. 1996 Jun;123(1-2):17-31. doi: 10.1016/0021-9150(96)05807-8. No abstract available. |
| Background | Scheller B. Drug-Eluting Balloons: The B.BRAUN Paclitaxel-Eluting Balloon Program: Device Characteristics, Experimental Findings, and Clinical. Outcomes in Patients with In-Stent Restenosis and for Small Vessels (PEPCAD I and II). Transcatheter Cardiovascular Therapeutics 2008; Oct 12-17 |
| 17101615 | Background | Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13. |
| Background | Additional Ongoing BRAUN Paclitaxel-Eluting Balloon Clinical Trials in Diabetics,Bifurcations and Chronic Total Occlusions (Other PEPCAD Studies). Mathey DG. Transcatheter Cardiovascular Therapeutics 2008;October 12-17, 2008 • Washington, DC. |
| 18360855 | Background | Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA. Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry. Catheter Cardiovasc Interv. 2008 Apr 1;71(5):629-35. doi: 10.1002/ccd.21452. |
| 18779447 | Background | Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. |
| Background | Ferrerio JL, Cequier A, Gómez JA, Maristany J, Fernández F, Gómez M et al. Contraindicaciones al inicio o interrupción precoz de la doble antiagregación en pacientes con indicación de intervencionismo coronario percutáneo. Rev Esp Cardiol 2007;60 Supl 2:1-192 pag 149. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |