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- Essai clinique NCT00231257
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Rochester
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring > 2.75mm and 3.5mm in diameter and > 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment > 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
4. The vessel 1cm distal to the target lesion is > 2.5mm in diameter;
5. Ejection Fraction must be > 40%;
6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
7. Male or non-pregnant female patients > 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.
Exclusion Criteria:
- The study target lesion has definite or possible thrombus present by angiographic criteria.
- The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
- Impaired renal function (Serum creatinine > 2.0mg/dl);
- The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
- The left ventricular ejection fraction is < 40%.
- The target vessel has previously sustained a perforation.
- Totally occluded vessel (TIMI 0 level);
- Prior stent within 5mm of target lesion;
- There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
- Has an ostial target lesion;
- Significant (> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
Cypher Bx Vitesse
|
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
|
Comparateur actif: 2
Brachytherapy
|
Brachytherapy
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
Délai: 9 months post-procedure.
|
9 months post-procedure.
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Revascularisation de la lésion cible (TLR) à 6 et 9 mois post-procédure.
Délai: 6 et 9 mois après la procédure
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6 et 9 mois après la procédure
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Revascularisation du vaisseau cible (TVR) à 6 et 9 mois après la procédure.
Délai: 6 et 9 mois après la procédure
|
6 et 9 mois après la procédure
|
Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).
Délai: 6 months post-procedure
|
6 months post-procedure
|
Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].
Délai: 6 months post-procedure
|
6 months post-procedure
|
Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).
Délai: Post-procedure and at six-month
|
Post-procedure and at six-month
|
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-proce
Délai: 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
|
30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
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Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.
Délai: post-procedure and six months
|
post-procedure and six months
|
Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.
Délai: 12 mo post-procedure
|
12 mo post-procedure
|
Rate of late thrombosis
Délai: Throughout study
|
Throughout study
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: David R. Holmes, Jr., MD, Mayo Clinic - Rochester, Minnesota
Publications et liens utiles
Publications générales
- 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.
- Holmes DR Jr, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA; SISR Investigators. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):439-48. doi: 10.1016/j.jcin.2008.05.010.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P02-6313
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