- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00140530
Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
A Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Prevention of Restenosis (ISAR-TEST-1)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Drug-eluting stents represent a major advance in the treatment of restenosis. They have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtained in various patient subsets, these devices are now used in almost 90% of the stent implantation procedures performed in US hospitals. Along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data, concern has arisen regarding the safety of these devices. At the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents. A growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery. Recently, we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations. Using a porcine coronary model of restenosis, we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation. More recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. While the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable, their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated.
Comparison:
Polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Munich, Tyskland, 80636
- Deutsches Herzzentrum Muenchen
-
Munich, Tyskland, 81675
- First Medizinische Klinik, Klinikum rechts der Isar
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients at least 18 years old
- Stable or unstable angina or a positive stress test
- "de novo" coronary artery lesions
- Written informed consent
Exclusion Criteria:
- Myocardial infarction within 48 h. before enrollment
- Target lesion located in left main trunk
- Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Due to randomisation patients got a Paclitaxel-eluting stent
|
patients has been implanted the Paclitaxel-eluting stent.
Andre navne:
|
Eksperimentel: 2
Due to randomization patients got a Rapamycin-eluting stent.
|
patients has been implanted the Rapamycin-eluting stent.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
In-stent late luminal loss
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Angiographic restenosis at follow-up angiography
Tidsramme: 6 months
|
6 months
|
Need for target lesion revascularization due restenosis at 9 months
Tidsramme: 9 months
|
9 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23.
- Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.
- Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51. doi: 10.1161/01.cir.0000041632.02514.14.
- Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.
- Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3.
- King L, Byrne RA, Mehilli J, Schomig A, Kastrati A, Pache J. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):E23-8. doi: 10.1002/ccd.24375. Epub 2012 May 4.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Koronar sygdom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Paclitaxel
- Sirolimus
Andre undersøgelses-id-numre
- GE IDE No. S02103
- AZ 504/02
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 .
Kliniske forsøg med Koronar sygdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aorta origin of the coronary artery (AAOCA)Italien
Kliniske forsøg med Paclitaxel-eluting stent (Taxus)
-
Medtronic VascularAfsluttet
-
Associations for Establishment of Evidence in InterventionsAfsluttet
-
Boston Scientific CorporationAfsluttetKoronararteriesygdomForenede Stater
-
Sydney South West Area Health ServiceUkendtKoronar angioplastik og stenting | Single de Novo koronararteriestenoserAustralien
-
Centre Chirurgical Marie LannelongueCentre Hospitalier Universitaire de Nice; University Hospital, Limoges; Hôpital... og andre samarbejdspartnereAfsluttetDiabetes | Koronar hjertesygdom | Kronisk total okklusion af koronararterie | Restenose | Vaskulære læsionerFrankrig
-
North Texas Veterans Healthcare SystemUS Department of Veterans Affairs; University of Arkansas; Michael E. DeBakey... og andre samarbejdspartnereAfsluttetÅreforkalkning | Koronararterie bypassForenede Stater, Grækenland
-
Seoul National University HospitalB. Braun Melsungen AGUkendt
-
Aarhus University Hospital SkejbyOdense University Hospital; University of Copenhagen; University of AarhusAfsluttetKoronararteriesygdom | Hjertekrampe
-
Institute of Cardiology, Warsaw, PolandUkendtStenose i saphenøs venetransplantat, lægemiddeleluerende stentPolen
-
CID - Carbostent & Implantable DevicesAfsluttetStabil angina | Ustabil angina | Dokumenteret tavs iskæmiFrankrig, Tyskland, Belgien, Italien