RIBS IV (Restenosis Intra-stent af lægemiddel-eluerende stents: Paclitaxel-eluerende ballon vs Everolimus-eluerende stent) (RIBS IV)
23. juni 2011 opdateret af: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
RIBS IV (Restenosis Intra-stent af lægemiddel-eluerende stents: Paclitaxel-eluerende ballon vs Everolimus-eluerende stent). Et prospektivt, multicenter og randomiseret klinisk forsøg
Behandling af patienter med lægemiddel-eluerende stent-restenose er fortsat en udfordring.
Denne undersøgelse vil vurdere, hvilken interventionsstrategi (paclitaxel-eluerende ballon vs everolimus-eluerende stent) der er overlegen i behandlingen af patienter, der lider af lægemiddel-eluerende stent-restenose.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Behandling af patienter med lægemiddel-eluerende stent-restenose er fortsat en stor klinisk og teknisk udfordring. I øjeblikket anvendes lægemiddel-eluerende stents i vid udstrækning til behandling af disse patienter. For nylig er værdien af den paclitaxel-eluerende ballon i dette kliniske miljø blevet foreslået. Der er dog kun sparsomme observationsdata om værdien af denne nye ballon hos patienter med lægemiddel-eluerende stent-restenose.
Dette prospektive, multicenter, randomiserede kliniske forsøg vil sammenligne to forskellige interventionsstrategier (nemlig paclitaxel-eluerende ballon vs everolimus-eluerende stent) i behandlingen af patienter med lægemiddel-eluerende stent-restenose.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
310
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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A Coruña, Spanien, 15006
- Rekruttering
- Complejo Hospitalario Universitario A Coruna
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Kontakt:
- Nicolas Vazquez, MD
- Telefonnummer: 0034981178031
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Ledende efterforsker:
- Nicolas Vazquez, MD
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Alicante, Spanien, 03010
- Rekruttering
- Hospital General Universitario de Alicante
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Kontakt:
- Vicente Mainar, MD
- Telefonnummer: 0034965938561
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Ledende efterforsker:
- Vicente Mainar, MD
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Almeria, Spanien, 04009
- Rekruttering
- Complejo Hospitalario de Torrecardenas
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Kontakt:
- Rosa Lazaro, MD,
- Telefonnummer: +34950016989
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Ledende efterforsker:
- Rosa Lazaro, MD
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Badajoz, Spanien, 06080
- Rekruttering
- Hospital Universitario Infanta Cristina
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Kontakt:
- Jose R Lopez-Minguez, MD
- Telefonnummer: 0034924218125
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Ledende efterforsker:
- Jose R Lopez-Minguez, MD
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Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic De Barcelona
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Kontakt:
- Monica Masotti, MD
- Telefonnummer: 0034932275519
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Ledende efterforsker:
- Monica Masotti, MD
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Barcelona, Spanien, 08025
- Rekruttering
- Hospital De La Santa Creu I Sant Pau
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Kontakt:
- Vicens Marti, MD
- Telefonnummer: 0034935565851
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Ledende efterforsker:
- Vicens Marti, MD
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Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d´Hebrón
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Kontakt:
- Joan Angel, MD
- Telefonnummer: 0034934893000
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Ledende efterforsker:
- Joan Angel, MD
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Granada, Spanien, 18014
- Rekruttering
- Hospital Universitario Virgen de las Nieves
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Kontakt:
- Rafael Melgares, MD
- Telefonnummer: 0034958020564
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Ledende efterforsker:
- Rafael Melgares, MD
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Kontakt:
- Maria T Velazquez, MD
- Telefonnummer: 0034913908440
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Ledende efterforsker:
- Maria T Velazquez, MD
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Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz
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Kontakt:
- Raul Moreno, MD
- Telefonnummer: 0034917277000
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Ledende efterforsker:
- Raul Moreno, MD
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos
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Kontakt:
- Fernnado Alfonso, MD
- Telefonnummer: 0034913303289
- E-mail: falf@hotmail.com
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Ledende efterforsker:
- Fernando Alfonso, MD, PhD
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Madrid, Spanien, 28006
- Rekruttering
- Hospital Universitario de La Princesa
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Kontakt:
- Bernhard Seidelberger, MD
- Telefonnummer: 0034915202200
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Ledende efterforsker:
- Bernhard Seidelberger, MD
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Malaga, Spanien, 29010
- Rekruttering
- Hospital Universitario Virgen de la Victoria
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Kontakt:
- Jose M Hernandez, MD
- Telefonnummer: 0034951032000
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Ledende efterforsker:
- Jose M Hernandez, MD
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Malaga, Spanien, 29010
- Rekruttering
- Hospital Universitario Carlos Haya
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Kontakt:
- Cristobal Urbano, MD
- Telefonnummer: 0034951290000
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Ledende efterforsker:
- Cristobal Urbano, MD
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Toledo, Spanien, 45004
- Rekruttering
- Complejo Hospitalario de Toledo
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Kontakt:
- Jose Moreu, MD
- Telefonnummer: +34925269188
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Ledende efterforsker:
- Jose Moreu, MD
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Valencia, Spanien, 46010
- Rekruttering
- Hospital Clinico Universitario de Valencia
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Kontakt:
- Vicent Bodi, MD
- Telefonnummer: 0034963862658
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Ledende efterforsker:
- Vicent Bodi, MD
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Valencia, Spanien, 46014
- Rekruttering
- Hospital General Universitario de Valencia
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Kontakt:
- Francisco Pomar, MD
- Telefonnummer: 0034961972000
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Ledende efterforsker:
- Francisco Pomar, MD
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Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Universitario Miguel Servet
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Kontakt:
- Maria Cruz Ferrer, MD, PhD
- Telefonnummer: +34976562565
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Ledende efterforsker:
- Maria Cruz Ferrer, MD, PhD
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Asturias
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Oviedo, Asturias, Spanien, 33006
- Rekruttering
- Hospital Central de Asturias
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Kontakt:
- Raquel del Valle, MD
- Telefonnummer: 0034985106112
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Ledende efterforsker:
- Raquel del Valle, MD
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Barcelona
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L´Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekruttering
- Hospital Universitari de Bellvitge
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Kontakt:
- Angel Cequier, MD
- Telefonnummer: 0034932607539
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Ledende efterforsker:
- Angel Cequier, MD
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Rekruttering
- Hospital Universitario Marques de Valdecilla
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Kontakt:
- Javier Zueco, MD
- Telefonnummer: 0034942202744
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Ledende efterforsker:
- Javier Zueco, MD
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Illes Balears
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Palma de Mallorca, Illes Balears, Spanien, 07014
- Rekruttering
- Hospital Universitari Son Dureta
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Kontakt:
- Armando Bethencourt, MD
- Telefonnummer: 0034971175476
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Ledende efterforsker:
- Armando Bethencourt, MD
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Madrid
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Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro Majadahonda
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Kontakt:
- Javier Goicolea, MD
- Telefonnummer: 0034911917408
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Ledende efterforsker:
- Javier Goicolea, MD
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Navarra
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Pamplona, Navarra, Spanien, 31008
- Rekruttering
- Hospital Provincial de Navarra
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Kontakt:
- Roman Lezaun, MD
- Telefonnummer: 0034848422345
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Ledende efterforsker:
- Roman Lezaun, MD
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Pontevedra
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Vigo, Pontevedra, Spanien, 36200
- Rekruttering
- Complejo Hospitalario Universitario de Vigo
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Kontakt:
- Andres Iñiguez, MD
- Telefonnummer: 0034986811163
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Ledende efterforsker:
- Andres Iñiguez, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
PATIENT:
- Alder mellem 20 og 85 år
- Underskrevet informeret samtykke
- Accept af sen angiografisk kontrol (6-9 måneder)
- Angina og/eller objektive tegn på iskæmi
LÆSION:
- In-Stent restenose (> 50% visuel) enhver lægemiddel-eluerende stent
- Kendskab til tidligere stentplacering
Ekskluderingskriterier:
PATIENT:
- Inkludering i en anden klinisk forskningsprotokol
- Kvinder i den fødedygtige alder
- Alvorlig associeret systemisk sygdom (herunder nyre- eller leversvigt)
- Alvorlig depression af venstre ventrikulær ejektionsfraktion (LVEF <25 %)
- Sygdom, der påvirker den forventede levetid
- Nyligt myokardieinfarkt (<7 dage)
- Tidspunkt for implantation af den foregående DES <1 måned
- Alvorlige vanskeligheder forventes ved sen angiografisk undersøgelse
LÆSION:
- Angiografisk svigt under implementering af initial stent (reststenose > 50 %)
- Billede af stor trombe in-stent (> kardiameter)
- Tortuositet eller Ca++ med meget alvorlige vanskeligheder under forudgående stentplacering
- Kardiameter <2 mm (visuelt estimat)
- Restenose kun "uden for" stenten (kanten af stenten påvirkes ikke)
- Fuldstændig okklusiv restenose (100 %, TIMI 0)
- Meget diffus restenose (> 30 mm længde)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Paclitaxel-eluerende ballon
Paclitaxel-eluerende ballon (SeQuent Please, B. Braun)
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Ballonangioplastik
|
|
Aktiv komparator: Everolimus-eluerende stent
Everolimus-eluerende stent (Xience Prime, Abbott Vascular)
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Stentimplantation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Minimal lumen diameter
Tidsramme: Sen angiografisk opfølgning (6-9 måneder)
|
Sammenligning af minimal lumendiameter ved sen angiografisk opfølgning (6-9 måneder) mellem de 2 behandlingsstrategier (ved kvantitativ koronar angiografi)
|
Sen angiografisk opfølgning (6-9 måneder)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kombinerede kliniske og angiografiske endepunkter
Tidsramme: 6-9 måneder, 1 år og 3 år
|
A) Effektivitetsresultater: A1) Angiografisk: 1) Restenoserate, 2) % diameterstenose, 3) akut gevinst, 4) sent tab, 5) nettoforøgelse A2) Sammensætning af død, myokardieinfarkt, revaskularisering af målkar og analyse af individuelle hændelser B) Sikkerhedsresultater: Stenttrombose, blødningsepisoder. C) Forudspecificerede variabler til undergruppeanalyse (RIBS I) D) Lagdeling (længde og kant). Type stent og elueret lægemiddel E) Indflydelse af kliniske variabler og restenosemønstre på resultatet |
6-9 måneder, 1 år og 3 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Fernando Alfonso, MD, PhD, Hospital San Carlos, Madrid
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.
- 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.
- Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.
- Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71. doi: 10.1001/jama.293.2.165.
- Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.
- Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
- Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Yokoi H, Hamasaki N, Nosaka H, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996 Feb 29;334(9):561-6. doi: 10.1056/NEJM199602293340903.
- Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
- Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.
- Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol. 2001 Sep;38(3):672-9. doi: 10.1016/s0735-1097(01)01458-9.
- Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0.
- Alfonso F, Melgares R, Mainar V, Lezaun R, Vazquez N, Tascon J, Pomar F, Cequier A, Angel J, Perez-Vizcayno MJ, Sabate M, Banuelos C, Fernandez C, Garcia JM; Restensois Intra-stent: Ballon angioplasty versus elective Stenting (RIBS) Investigators. Therapeutic implications of in-stent restenosis located at the stent edge. Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS) randomized trial. Eur Heart J. 2004 Oct;25(20):1829-35. doi: 10.1016/j.ehj.2004.07.019.
- Alfonso F, Auge JM, Zueco J, Bethencourt A, Lopez-Minguez JR, Hernandez JM, Bullones JA, Calvo I, Esplugas E, Perez-Vizcayno MJ, Moreno R, Fernandez C, Hernandez R, Gama-Ribeiro V; RIBS Investigators. Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study. J Am Coll Cardiol. 2005 Sep 6;46(5):756-60. doi: 10.1016/j.jacc.2005.05.050.
- Alfonso F, Cequier A, Angel J, Marti V, Zueco J, Bethencourt A, Mantilla R, Lopez-Minguez JR, Gomez-Recio M, Moris C, Perez-Vizcayno MJ, Fernandez C, Macaya C, Seabra-Gomes R; Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) Investigators. Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial. Am Heart J. 2006 Mar;151(3):681.e1-681.e9. doi: 10.1016/j.ahj.2005.10.014.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Mantilla R, Moris C, Cequier A, Sabate M, Escaned J, Moreno R, Banuelos C, Suarez A, Macaya C; RIBS-II Investigators. A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006 Jun 6;47(11):2152-60. doi: 10.1016/j.jacc.2005.10.078.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Banuelos C, Bethencourt A, Lopez-Minguez JR, Angel J, Cequier A, Sabate M, Moris C, Zueco J, Seabra-Gomes R; Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Stent Implantation (RIBS-I) and Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Investigators. Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):459-67. doi: 10.1002/ccd.21694.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Iniguez A, Moris C, Cequier A, Sabate M, Escaned J, Jimenez-Quevedo P, Banuelos C, Suarez A, Macaya C; RIBS-II Investigators. Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol. 2008 Nov 11;52(20):1621-7. doi: 10.1016/j.jacc.2008.08.025.
- Baz JA, Pinar E, Albarran A, Mauri J; Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology. Spanish Cardiac Catheterization and Coronary Intervention Registry. 17th official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2007). Rev Esp Cardiol. 2008 Dec;61(12):1298-314. doi: 10.1016/s1885-5857(09)60057-8. English, Spanish.
- Alfonso F, Perez-Vizcayno MJ, Cruz A, Garcia J, Jimenez-Quevedo P, Escaned J, Hernandez R. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 May;5 Suppl D:D70-8.
- Pinar E, Albarran A, Baz JA, Mauri J. [Update on interventional cardiology]. Rev Esp Cardiol. 2009 Jan;62 Suppl 1:101-16. doi: 10.1016/s0300-8932(09)70045-4. Spanish.
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- Lopez-Palop R, Pinar E, Lozano I, Saura D, Pico F, Valdes M. Utility of the fractional flow reserve in the evaluation of angiographically moderate in-stent restenosis. Eur Heart J. 2004 Nov;25(22):2040-7. doi: 10.1016/j.ehj.2004.07.016.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Goicolea J, Fernandez-Ortiz A, Escaned J, Banuelos C, Fernandez C, Macaya C. Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis. Am J Cardiol. 1999 Apr 15;83(8):1268-70, A9. doi: 10.1016/s0002-9149(99)00071-5.
- Alfonso F, Suarez A, Perez L, Sabate M, Moreno R, Banuelos C. Intravascular ultrasound in patients with challenging in-stent restenosis: importance of precise stent visualization. J Interv Cardiol. 2006 Apr;19(2):153-9. doi: 10.1111/j.1540-8183.2006.00123.x.
- Mehran R, Mintz GS, Popma JJ, Pichard AD, Satler LF, Kent KM, Griffin J, Leon MB. Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. Am J Cardiol. 1996 Sep 15;78(6):618-22. doi: 10.1016/s0002-9149(96)00381-5.
- Wong SC, Baim DS, Schatz RA, Teirstein PS, King SB 3rd, Curry RC Jr, Heuser RR, Ellis SG, Cleman MW, Overlie P, et al. Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group. J Am Coll Cardiol. 1995 Sep;26(3):704-12. doi: 10.1016/0735-1097(95)00217-r.
- Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M, Martini G, Blengino S, Di Mario C, Colombo A. Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. J Am Coll Cardiol. 1997 Jul;30(1):186-92. doi: 10.1016/s0735-1097(97)00142-3.
- Bauters C, Banos JL, Van Belle E, Mc Fadden EP, Lablanche JM, Bertrand ME. Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis. Circulation. 1998 Feb 3;97(4):318-21. doi: 10.1161/01.cir.97.4.318.
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- Alfonso F, Garcia P, Fleites H, Pimentel G, Sabate M, Hernandez R, Escaned J, Banuelos C, Perez-Vizcayno MJ, Moreno R, Macaya C. Repeat stenting for the prevention of the early lumen loss phenomenon in patients with in-stent restenosis. Angiographic and intravascular ultrasound findings of a randomized study. Am Heart J. 2005 Feb;149(2):e1-8. doi: 10.1016/j.ahj.2004.06.022.
- Alfonso F, Hernandez C, Perez-Vizcayno MJ, Hernandez R, Fernandez-Ortiz A, Escaned J, Banuelos C, Sabate M, Sanmartin M, Fernandez C, Macaya C. Fate of stent-related side branches after coronary intervention in patients with in-stent restenosis. J Am Coll Cardiol. 2000 Nov 1;36(5):1549-56. doi: 10.1016/s0735-1097(00)00927-x.
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- Alfonso F. Paclitaxel-Eluting Balloons for In-Stent Restenosis. Circulation 2010. In press.
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- Whan Lee C, Kim SH, Suh J, Park DW, Lee SH, Kim YH, Hong MK, Kim JJ, Park SW, Park SJ. Long-term clinical outcomes after sirolimus-eluting stent implantation for treatment of restenosis within bare-metal versus drug-eluting stents. Catheter Cardiovasc Interv. 2008 Apr 1;71(5):594-8. doi: 10.1002/ccd.21399.
- Steinberg DH, Gaglia MA Jr, Pinto Slottow TL, Roy P, Bonello L, De Labriolle A, Lemesle G, Torguson R, Kineshige K, Xue Z, Suddath WO, Kent KM, Satler LF, Pichard AD, Lindsay J, Waksman R. Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents. Am J Cardiol. 2009 Feb 15;103(4):491-5. doi: 10.1016/j.amjcard.2008.09.107.
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- Alfonso F, Perez-Vizcayno MJ, Cuesta J, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Masotti M, Zueco J, Cequier A, Velazquez M, Moreno R, Mainar V, Dominguez A, Moris C, Molina E, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez-Perez C; RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology). 3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents. JACC Cardiovasc Interv. 2018 May 28;11(10):981-991. doi: 10.1016/j.jcin.2018.02.037.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Forventet)
1. juli 2012
Datoer for studieregistrering
Først indsendt
12. november 2010
Først indsendt, der opfyldte QC-kriterier
12. november 2010
Først opslået (Skøn)
15. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2011
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RIBS IV
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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