A Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold
26 juillet 2016 mis à jour par: Yonsei University
A Randomized Controlled Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold
It is well-known that non-optimal stent implantation associated with under-expansion or incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher incidence of restenosis and stent thrombosis.
OCT-guided PCI with metallic stent has previously been shown to be safe and feasible, resulting in better clinical outcomes compared with angiography-only guided PCI.
Everolimus-eluting bioabsorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
BVS has a number of proposed advantages over current metallic stent technology.
These include elimination of chronic sources of vessel irritation and inflammation, which can reduce the potential risk of late scaffold thrombosis after complete scaffold bioresorption.
Although the current generation of the Absorb BVS have larger strut thickness of 150 μm compared with 80 μm of strut of Xience stent, the acute recoil of the polymeric device was similar to that of metallic stent.
However, operators tented to use dilating devices less aggressively because of the concerns about limitation in elongation-at-break of polylactide.
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis.
OCT-guidance may improve more optimized scaffold placement and also better outcomes.
Therefore, investigators will compare OCT guidance and angiography-only guidance for PCI with BVS regarding incomplete scaffold apposition and neointimal scaffold coverage.
Investigators are also going to compare these two strategies regarding clinical outcomes with verification of the cut-off value by OCT-acquired uncovered scaffold rate.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
13
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Seoul, Corée, République de, 120-752
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
19 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patients ≥ 19 years old
- Patients with ischemic heart disease who are considered for coronary revascularization with PCI
- Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single BVS ≤ 25mm
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion Criteria:
- Myocardial infarction
- Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- Reference vessel diameter <2.5 mm or >3.5 mm
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Lesions requiring 2 or more BVS
- Contraindication or hypersensitivity to anti-platelet agents or contrast media
- Treated with any metallic stent or BVS within 3 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
|
Comparateur actif: Angiography-guidance
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality.
|
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality.
|
|
Expérimental: OCT-guidance
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before and after stent implantation.
OCT study should be checked at the final post-procedure and stent implantation is optimized.
|
Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus.
For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before and after stent implantation.
OCT study should be checked at the final post-procedure and stent implantation is optimized.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of uncovered scaffold struts
Délai: six months
|
Percentage of uncovered scaffold struts between OCT guidance vs. angiography-only guidance PCI on 6 month OCT
|
six months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Major cardiac and cerebrovascular adverse events (MACCEs)
Délai: until one year
|
Cardiac death, myocardial infarction, target vessel revascularization, stent thrombosis, cerebrovascular accident and major bleeding between OCT guidance vs. angiography-only guidance PCI until 12 months *Major bleeding ; causing mortality, hypovolemic shock or severe hypotension requiring inotropes or surgery, intrapericardial with tamponade, significant disabling (e.g. intraocular bleeding leading to loss of vision), symptomatic intracranial haemorrhage, intraocular bleeding leading to loss of vision, hemoglobin drop ≥ 3g/dL, or requiring transfusion more than 2 units |
until one year
|
|
Percentage of incomplete scaffold struts apposition
Délai: six months after stent implantation
|
Scaffold strut malapposition: Malapposition is defined by a clear seperation between the abluminal side of the strut and the vessel wall.
As a result, scaffold malapposition is defined as the presence of any malapposed struts.
percentage of malapposed struts (% malapposed strut) was the ratio of malapposed struts from total analyzable struts.
|
six months after stent implantation
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2015
Achèvement primaire (Réel)
1 mai 2016
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
3 juin 2015
Première soumission répondant aux critères de contrôle qualité
4 juin 2015
Première publication (Estimation)
9 juin 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 juillet 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juillet 2016
Dernière vérification
1 juillet 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1-2015-0019
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 .