- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02238054
Fransk observatorium som evaluerer bruken av intrakoronarprotese ABSORB BVS (FRANCE-ABSORB)
Observasjonsstudie, fransk, prospektiv, multisenter vurdert ved bruk av intravaskulær protese ABSORB BVS.
ABSORB BVS er en protese av ny type. Denne studien vil prospektivt evaluere alle prosedyrer for koronar angioplastikk med implantasjon av minst én BVS med en klinisk oppfølging av alle pasienter implantert med ABSORB BVS. Dette nasjonale observatoriet vil samle alle hendelser knyttet til produkt og/eller prosedyre
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Rouen, Frankrike
- Clinique Saint Hilaire
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Alle avdelinger for kardiologi, fra franske helseinstitusjoner, som er autorisert til å implementere, kan delta i observatoriet.
Det er anslått at denne prosedyren vil bli utført av 50 til 60 steder som utfører installasjonen av BVS. Listen over sentre er skalerbar, antallet kan forventes å øke.
Beskrivelse
Inklusjonskriterier:
- Pasient tilknyttet Folketrygden
- Pasienten er i stand til å vurdere og forstå risikoene, fordelene og alternative behandlinger ved ABSORB, å godta å delta i studien (ved å signere det informerte samtykket etter å ha lest nyhetsbrevet)
- Pasienter for hvilke en prosedyre utføres koronar angioplastikk med implantasjon av minst en BVS.
- Pasient som tillater oppfølging som definert i studien
Ekskluderingskriterier:
- Gravid pasient
- Pasient som ikke kan gi informert samtykke
- Pasient med in-stent restenose eller saphenous vene bypass
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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ABSORB BVS
Alle pasienter med koronar angioplastikk og implantasjon av minst én ABSORB BVS
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Store uønskede hjertehendelser etter 1 år
Tidsramme: 1 år
|
Ved 1 års oppfølging, for å evaluere frekvensen av MACE (Major Adverse Cardiac Events) definert som følger:
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1 år
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mål karrevaskularisering etter 1 år
Tidsramme: 1 år
|
Ved 1 års oppfølging, for å evaluere frekvensen av målkarrevaskularisering (TVR)
|
1 år
|
Hyppighet av stenttrombose ved 1 år
Tidsramme: 1 år
|
Ved 1 års oppfølging, for å evaluere frekvensen av stenttrombose som ARC-definisjoner:
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1 år
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
- Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
- Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
- Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
- Diletti R, Onuma Y, Farooq V, Gomez-Lara J, Brugaletta S, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn R, Smits P, Koolen J, Meredith I, Li D, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol. 2011 Jul 12;58(3):258-64. doi: 10.1016/j.jacc.2011.02.052.
- Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
- Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
- Abbott JD, Voss MR, Nakamura M, Cohen HA, Selzer F, Kip KE, Vlachos HA, Wilensky RL, Williams DO. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol. 2007 Nov 20;50(21):2029-36. doi: 10.1016/j.jacc.2007.07.071.
- Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
- Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
- Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.
- Ormiston J, Webster M. Absorbable coronary stents. Lancet. 2007 Jun 2;369(9576):1839-1840. doi: 10.1016/S0140-6736(07)60829-0. No abstract available.
- Ramcharitar S, Serruys PW. Fully biodegradable coronary stents : progress to date. Am J Cardiovasc Drugs. 2008;8(5):305-14. doi: 10.2165/00129784-200808050-00003.
- Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.
- Colombo A, Sharp AS. The bioabsorbable stent as a virtual prosthesis. Lancet. 2009 Mar 14;373(9667):869-70. doi: 10.1016/S0140-6736(09)60521-3. No abstract available.
- Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. No abstract available.
- Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. No abstract available.
- Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3.
- Onuma Y, Serruys PW, Ormiston JA, Regar E, Webster M, Thuesen L, Dudek D, Veldhof S, Rapoza R. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010 Sep;6(4):447-53. doi: 10.4244/EIJ30V6I4A76.
- Bittl JA. Bioresorbable stents: the next revolution. Circulation. 2010 Nov 30;122(22):2236-8. doi: 10.1161/CIRCULATIONAHA.110.988469. Epub 2010 Nov 15. No abstract available.
- Gori T, Schulz E, Hink U, Wenzel P, Post F, Jabs A, Munzel T. Early outcome after implantation of Absorb bioresorbable drug-eluting scaffolds in patients with acute coronary syndromes. EuroIntervention. 2014 Jan 22;9(9):1036-41. doi: 10.4244/EIJV9I9A176.
- Simsek C, Magro M, Onuma Y, Boersma E, Smits P, Dorange C, Veldhof S, Regar E, Serruys PW, van Geuns RJ. Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH). EuroIntervention. 2014 Jun;10(2):236-40. doi: 10.4244/EIJV10I2A38.
- Meincke F, Kuck KH, Bergmann MW. Delivery of a bioresorbable vascular scaffold to complex lesions. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):774-8. doi: 10.1002/ccd.25105. Epub 2014 Jul 30.
- Kajiya T, Liang M, Sharma RK, Lee CH, Chan MY, Tay E, Chan KH, Tan HC, Low AF. Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention. 2013 Aug 22;9(4):501-4. doi: 10.4244/EIJV9I4A80.
- Gogas BD, Bourantas CV, Garcia-Garcia HM, Onuma Y, Muramatsu T, Farooq V, Diletti R, van Geuns RJ, De Bruyne B, Chevalier B, Thuesen L, Smits PC, Dudek D, Koolen J, Windecker S, Whitbourn R, McClean D, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Ormiston JA, Serruys PW. The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials. EuroIntervention. 2013 Oct;9(6):709-20. doi: 10.4244/EIJV9I6A115.
- Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012 Nov;164(5):654-63. doi: 10.1016/j.ahj.2012.08.010.
- Diletti R, Farooq V, Girasis C, Bourantas C, Onuma Y, Heo JH, Gogas BD, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn RJ, Smits P, Koolen J, Meredith I, Li X, Miquel-Hebert K, Veldhof S, Garcia-Garcia HM, Ormiston JA, Serruys PW. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart. 2013 Jan;99(2):98-105. doi: 10.1136/heartjnl-2012-302598. Epub 2012 Oct 31.
- Garcia-Garcia HM, Schultz C, Duckers E, Regar E, Ligthart J, Serruys PW, van Geuns RJ. Five-year follow-up of the ABSORB bioresorbable everolimus-eluting vascular scaffold system: multimodality imaging assessment. EuroIntervention. 2013 Feb 22;8(10):1126-7. doi: 10.4244/EIJV8I10A187. No abstract available.
- Gogas BD, Farooq V, Onuma Y, Serruys PW. The ABSORB bioresorbable vascular scaffold: an evolution or revolution in interventional cardiology? Hellenic J Cardiol. 2012 Jul-Aug;53(4):301-9. No abstract available.
- Brugaletta S, Garcia-Garcia HM, Onuma Y, Serruys PW. Everolimus-eluting ABSORB bioresorbable vascular scaffold: present and future perspectives. Expert Rev Med Devices. 2012 Jul;9(4):327-38. doi: 10.1586/erd.12.17. Epub 2012 Mar 16.
- Gomez-Lara J, Diletti R, Brugaletta S, Onuma Y, Farooq V, Thuesen L, McClean D, Koolen J, Ormiston JA, Windecker S, Whitbourn R, Dudek D, Dorange C, Veldhof S, Rapoza R, Regar E, Garcia-Garcia HM, Serruys PW. Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study. EuroIntervention. 2012 Jun 20;8(2):214-24. doi: 10.4244/EIJV8I2A35.
- Sarno G, Bruining N, Onuma Y, Garg S, Brugaletta S, De Winter S, Regar E, Thuesen L, Dudek D, Veldhof S, Dorange C, Garcia-Garcia HM, Ormiston JA, Serruys PW. Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. Int J Cardiovasc Imaging. 2012 Jan;28(1):51-8. doi: 10.1007/s10554-010-9769-y. Epub 2011 Jan 7.
- Cayla G, Koning R, Fajadet J, Sainsous J, Carrie D, Elhadad S, Tarragano F, Lefevre T, Ranc S, Ghostine S, Garot P, Marco F, Maillard L, Motreff P, Le Breton H; FRANCE ABSORB investigators. Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry. Arch Cardiovasc Dis. 2019 Feb;112(2):113-123. doi: 10.1016/j.acvd.2018.09.007. Epub 2019 Jan 7.
- Lhermusier T, Carrie D, Cayla G, Fajadet J, Sainsous J, Elhadad S, Tarragano F, Chevalier B, Ranc S, Curinier C, Le Breton H, Koning R; FRANCE ABSORB Investigators. Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry. Catheter Cardiovasc Interv. 2021 Sep;98(3):511-519. doi: 10.1002/ccd.29369. Epub 2020 Nov 19.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 14249
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