- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01583608
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease (ASSURE)
ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry
Aperçu de l'étude
Statut
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bernau, Allemagne, 16321
- Herzzentrum Brandenburg in Bernau
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Coburg, Allemagne, 96450
- Klinikum Coburg GmbH
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Essen, Allemagne, 45138
- Elisabeth-Krankenhaus Essen GmbH
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Hamburg, Allemagne, 22527
- Medical Care Center Prof. Mathey, Prof. Schofer GmbH
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Kiel, Allemagne, 24105
- Universitätsklinikum Schleswig-Holstein
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Ulm, Allemagne, 89081
- Universitatsklinikum Ulm
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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
The recommendation to implant BVS in an individual patient is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated:
Eligible:
Regarding to patient
- Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, NSTEMI and unstable angina) due to one or more de novo native coronary artery lesions
- Patients with evidence of myocardial ischemia
Regarding to lesion
- Reference vessel diameter ≥ 2.0 mm and ≤ 3.8 mm, visually estimated and by online QCA
- Percent diameter stenosis ≥ 50% and < 100%, visually estimated and by online QCA
- TIMI ≥1
- Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion
- Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure
- In case of >1 target lesions, those should be from different epicardial vessels
Not eligible:
Regarding to patient
- Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated
- Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated
- Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
- Patient is currently experiencing clinical symptoms consistent with STEMI
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction < 30%
- Patient has received a heart transplant or any other organ transplant or is waiting for any organ transplant
- Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after procedure
- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease
- Patient is receiving or scheduled to receive chronic anticoagulation therapy
- Elective surgery is planned within the first 6 month after the procedure that will require discontinuing either aspirin or clopidogrel
- Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of
- < 3000 cells/mm3, or documented or suspected liver disease
- Patient has known renal insufficiency
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has cerebrovascular accident or transient ischemic neurological attack within the past six month
- Patient has had a significant GI or urinary bleed within the past six months
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non.compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., les than one year)
- Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal
Regarding to lesion
- Aorto-ostial location
- Left main location
- Located within 2 mm of the origin of LAD or LCX
- Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation with side branch vessel ≥ 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
- Total occlusion (TIMI flow 0), prior to wire passing
- Excessive tortuosity proximal to or within the lesion (extreme angulation (≥ 90°) proximal to or within the lesion)
- Heavy calcification
- Restenotic from previous intervention
- Target vessel is containing thrombus
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
Délai: at 24 months
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Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
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at 24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Acute procedural success
Délai: At the end of hospital stay (maximum of 7 days)
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Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site.
Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days).
In dual target lesion setting both lesions must meet clinical procedure success criteria.
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At the end of hospital stay (maximum of 7 days)
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Acute device success
Délai: At time of intervention
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Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system.
Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.
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At time of intervention
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Scaffold thrombosis
Délai: At time of intervention, and at 6, 12, 24, 36 months
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At time of intervention, and at 6, 12, 24, 36 months
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Cardiac death
Délai: At time of intervention, and at 6, 12,24, 36 months
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At time of intervention, and at 6, 12,24, 36 months
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Myocardial infarction
Délai: At time of intervention, and at 6, 12, 24 36 months
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At time of intervention, and at 6, 12, 24 36 months
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Ischemia driven target lesion revascularisation (TLR)
Délai: At time of intervention, and at 6, 12, 24, 36 months
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Target lesion denominates scaffolded segment and 5 mm beyond.
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At time of intervention, and at 6, 12, 24, 36 months
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Major Adverse Cardiac Event (MACE)
Délai: At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months
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Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death
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At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months
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Ischemia driven target vessel revascularisation (TVR)
Délai: at 6, 12, 24, 36 months
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TVR is ischemia driven.
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at 6, 12, 24, 36 months
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Ischemia driven target vessel failure (TVF)
Délai: at 6, 12, 24, 36 month
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at 6, 12, 24, 36 month
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In-lesion % diameter stenosis
Délai: Prior procedure
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Prior procedure
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In-scaffold % diameter stenosis
Délai: At time of intervention and at angiographic FU if applicable
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At time of intervention and at angiographic FU if applicable
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Minimal lumen diameter (MLD)
Délai: Prior and post procedure and at FU if applicable
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Prior and post procedure and at FU if applicable
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In-scaffold late lumen loss (LLL)
Délai: At angiographic follow-up if applicable
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At angiographic follow-up if applicable
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Proximal and distal late lumen loss (LLL)
Délai: At angiographic follow-up if applicable
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At angiographic follow-up if applicable
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In-lesion late lumen loss
Délai: At angiographic follow-up if applicable
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At angiographic follow-up if applicable
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Response to nitroglycerin
Délai: Before scaffold implantation, during angiographic follow-up if applicable
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Before scaffold implantation, during angiographic follow-up if applicable
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In-lesion angiographic binary restenosis (≥ 50%)
Délai: At angiographic follow-up if applicable
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At angiographic follow-up if applicable
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Curvature (cm-1)
Délai: Prior and post procedure and at angiographic follow-up if applicable
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treated region
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Prior and post procedure and at angiographic follow-up if applicable
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Angulation (°)
Délai: Prior and post procedure and at angiographic follow-up if applicable
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Treated region
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Prior and post procedure and at angiographic follow-up if applicable
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Clinical success
Délai: At time of intervention, and at 6, 12, 24, 36 months
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Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
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At time of intervention, and at 6, 12, 24, 36 months
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Coronary artery bypass grafting (CABG)
Délai: at 6, 12, 24, 36 month
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at 6, 12, 24, 36 month
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Detlef G Mathey, MD, Medical Care Center Prof. Mathey, Prof. Schofer GmbH
Publications et liens utiles
Publications générales
- Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
- Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
- Diletti R, Onuma Y, Farooq V, Gomez-Lara J, Brugaletta S, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn R, Smits P, Koolen J, Meredith I, Li D, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol. 2011 Jul 12;58(3):258-64. doi: 10.1016/j.jacc.2011.02.052.
- Gomez-Lara J, Brugaletta S, Farooq V, van Geuns RJ, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Morel MA, Dorange C, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up. JACC Cardiovasc Interv. 2011 Jul;4(7):789-99. doi: 10.1016/j.jcin.2011.04.009.
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BVS 12
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