- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01174433
Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY) (SAFE-TRY)
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Currently available stents were designed for straight lesions, optimised to provide scaffolding (coverage and radial strength) and ease of deliverability. In straight lesions, these stents have been shown to provide superb acute and long-term results. One lesion subset that continues to challenge the interventionalist is bifurcations lesions. A number of different strategies have been employed with standard stents to address bifurcation lesions each of which have significant limitations. Large contemporary registries characterising current stent usage in bifurcating lesions have demonstrated decreased procedural success with increased rates in restenosis and thrombosis (acute, subacute and delayed). The limitations of currently available stents have led groups to develop stents designed specifically to treat bifurcation lesions. The Tryton Side-Branch Stent Stent TM (Tryton Medical, Inc., Newton, MA, USA) is a balloon expandable cobalt chromium stent, designed specifically to treat bifurcation lesions.
The primary objective of this study is to evaluate the safety and feasibility of the use of the Tryton bifurcation coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 2.5 - 5.0 mm, distal main branch of 2.5 - 5.0 mm, and side branch RVD 2.5 - 3.5 mm.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Castelfranco Veneto, Italie, 31033
- Castelfranco Veneto's Hospital
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Conegliano, Italie, 31015
- Conegliano's Hospital
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Mestre, Italie, 30170
- Angel's Hospital
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Mirano, Italie, 30035
- Mirano's Hospital
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Padua, Italie, 35128
- Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy
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Vicenza, Italie, 36100
- Vicenza's Hospital
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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:
General Inclusion Criteria
- Candidate for percutaneous coronary intervention & emergent coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease or a positive functional study
- Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
- Patient or patient's legal representative provided written informed consent
- Patient agrees to comply with follow-up evaluations
Angiographic Inclusion Criteria
- Target lesion in a single de novo true bifurcation lesion (Medina classification Type 1.1.1; 1.0.1; 0.1.1; 0.0.1) involving a native coronary artery with reference vessel diameter for the proximal main of 2.5 - 5.0 mm, distal main of 2.5 - 5.0 mm, & side branch RVD of 2.5 - 3.5 mm
- Target lesion in main vessel has stenosis of > 50% and <100%
- Syntax score < 32
Exclusion Criteria:
General Exclusion Criteria
- Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
- Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure
- Serum creatinine level >170 micromol/L within 7 days prior to index procedure
- Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes >2X laboratory upper limit of normal in the presence of a confirming cardiac specific biomarker (Troponin I or T)
- Previous stenting anywhere in target vessel
- Percutaneous coronary intervention (PCI) of non-target vessel within 30 days prior to procedure that results in any MAC(C)E event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal
- PCI of non-target vessel within 24 hours prior to procedure
- Planned PCI of the target vessel within 6 months post-procedure
- During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
- Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation
- History of stroke or transient ischemic attack (TIA) within prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Concurrent medical condition with life expectancy <12 months
- Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
Angiographic Exclusion Criteria
- Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
- Target lesion has any of following characteristics:
- Severely calcified
- Evidence of thrombus
- Syntax score ≥33
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)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Tryton bifurcation stent system
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Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure
Délai: 30 days (plus or minus 3 days)
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A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 30 days post procedure.
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30 days (plus or minus 3 days)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Angiographic and Procedural success
Délai: 30 days (plus or minus 3 days)
|
Acute device success, Technical Success, Clinical Procedural Success, Device malfunctions, Ease-of-Use parameters, Main branch and side branch angiographic endpoints, Main branch and side branch IVUS endpoints (Reference Lumen Area; Reference EEM Area; Lesion Lumen Area; Lesion EEM Area; Maximum Atheroma Thickness; Minimum Atheroma Thickness; Lesion Maximum Lumen Diameter; Lesion Minimum Lumen Diameter and derived Measurements; calcium measurement)
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30 days (plus or minus 3 days)
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Total volume of contrast used
Délai: 24 hours
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Total volume of contrast used, in mL
|
24 hours
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Total index PCI procedure time
Délai: 24 hours
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Total index PCI procedure time, in minutes
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24 hours
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Target vessel revascularization (TVR) rate
Délai: 9 months
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Target vessel revascularization (TVR) rate, at 9 months
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9 months
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Target lesion revascularization (TLR) rate
Délai: 9 months
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Target lesion revascularization (TLR) rate, at 9 months
|
9 months
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Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate
Délai: 9 months
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Major Adverse Cardiac and Cerebrovascular Events (MAC(C)E) rate, at 9 months
|
9 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Giuseppe Tarantini, MD, Ph.D., University of Padua, Department of Cardiac, Thoracic and Vascular Sciences
Publications et liens utiles
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
- 2040P
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Essais cliniques sur Tryton
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Tryton Medical, Inc.ComplétéAthérosclérose coronarienne de l'artère coronaire native | Lésions de bifurcation : lésions de novo de la branche principale et latérale de l'artère coronaire nativeÉtats-Unis