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- Essai clinique NCT00811616
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute (Maximus)
Safety And Efficacy Evaluation of Sirolimus Eluting Supralimus-Core™ Stent at MAX DDHV Institute in the Treatment of de Novo Native Coronary Artery Lesions
OBJECTIVES:
The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.
STUDY DESIGN:
This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. Patients were followed for twelve months post-procedure. All patients were to have a repeat angiography at 8 months.
STUDY POPULATION:
The study population consisted of approximately 105 patients with de novo native vessel obstructive coronary artery disease with no specific criteria. Patients from the daily practice were included. Patients had to meet all eligibility criteria for inclusion into the study.
ENDPOINTS:
The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days.
The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line Quantitative Coronary Angiography.
The following secondary efficacy endpoints were assessed
- Angiographic success
- Procedure success
- Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up.
- Clinically justified Target Lesion Revascularization (TLR) at 12 months
The following secondary safety endpoints were assessed:
- MACE until 12 months
- Device related SAEs until 12 months
- Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New Delhi, Inde, 110017
- Max Heart and Vascular Institute
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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:
- The patient must be >= 18 years of age;
- Symptomatic ischemic heart disease (CCS class 1 -4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- Vessel size of >= 2.5 and <= 3.5mm.
- Target lesions which can be covered by stent in a manner lesion stent ratio of at least 1.5.
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Target lesion stenosis is >50% and <100% (TIMI flow I) (visual estimate);
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
Exclusion Criteria:
- Women of childbearing potential;
- Impaired renal function (creatinine > 2.0 mg/dl or 177 µmol/l);
- Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
- Recipient of heart transplant;
- Restenotic or lesion in graft.
- Patient with a life expectancy less than 12 months;
- Known allergies to aspirin, clopidogrel bisulphate (Plavix), ticlopidine (Ticlid), heparin or stainless steel;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
Angiographic Exclusion criteria:
- Unprotected left main coronary artery disease with >=50% stenosis;
- Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other interventions such as angiojet, exciser, thrombolysis, etc.);
- Ejection fraction <= 30%;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Primary safety endpoint: Major Adverse Cardiac Events (MACE)
Délai: 30 days
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30 days
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Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.
Délai: 8 Month
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8 Month
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Mesures de résultats secondaires
Mesure des résultats |
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Secondary safety endpoints: - MACE until 12 months, Device related SAEs until 12 months, Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
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Secondary efficacy endpoints: Angiographic, Procedure success; acute gain, MLD, % DS, LL, mean diameter; In-stent pre-,post,8-month follow-up; Clinically justified TLR at 12 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Dr. Ashok Seth, Escorts Heart Institute & Research Centre
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
- The MAXIMUS study
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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