- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02137486
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques (MV:main branch)
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.
We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.
Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 52005
- Taipei City Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion
Exclusion Criteria:
- Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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sequential ballooning
include BMS or DES
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final kissing ballooning
include BMS or DES
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With Major Adverse Cardiac Events(MACE)
Délai: periprocedure up to 12 months
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Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).
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periprocedure up to 12 months
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Percentage of Participants With Cardiovascular Mortality(%)
Délai: periprocedure up to 12 months
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Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.
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periprocedure up to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With Angiographic Success(%)
Délai: periprocedure up to 12 months.
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Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.
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periprocedure up to 12 months.
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Percentage of Participants With Target Vessel Revascularization Rate
Délai: periprocedure up to 12 months.
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Percentage of Participants with target vessel revascularization rate, both arms
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periprocedure up to 12 months.
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Fluoroscopy Time(Minutes) of Each Participants
Délai: periprocedure up to 12 months.
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as medical chart record.
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periprocedure up to 12 months.
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Procedure Time(Minutes) of Each Participants
Délai: periprocedure up to 12 months.
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as medical chart record.
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periprocedure up to 12 months.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- TCHIRB-1030209-E
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