- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01915420
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions (ASSURE ROT)
Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Detlef G Mathey, Prof. Dr.
- Telefonní číslo: 152 +4940889009
- E-mail: dgmathey@web.de
Studijní místa
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Hamburg, Německo, 22391
- Nábor
- Medical Care Center Prof. Mathey, Prof. Schofer GmbH
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Kontakt:
- Detlef G Mathey, Prof. Dr.
- Telefonní číslo: 152 +4940889009
- E-mail: dgmathey@web.de
-
Dílčí vyšetřovatel:
- Joachim Schofer, Prof. Dr.
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Dílčí vyšetřovatel:
- Carsten Schwencke, PD Dr.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
The recommendation to implant BVS in an individual patient in whom rotational atherectomy of a complex target lesion has been conducted, 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 complex de novo native coronary artery lesions
- Patients with evidence of myocardial ischemia
Regarding to lesion
- Reference vessel diameter ≥ 2.5 mm and ≤ 3.8 mm, visually estimated or by online QCA
- Percent diameter stenosis ≥ 50% and < 100%, visually estimated or 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
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 noncompliance 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
Target lesion(s) meets none of the following criteria:
- 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
- Ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
- Excessive tortuosity proximal to or within the lesion (extreme angulation proximal to or within the lesion)
- Restenotic from previous intervention
Target vessel is not containing thrombus
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Major Adverse Cardiac Event (MACE)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Acute procedural success
Časové okno: 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
Časové okno: 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
Časové okno: At time of intervention, and at 6, 12, 24, and 36 months
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At time of intervention, and at 6, 12, 24, and 36 months
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Cardiac death
Časové okno: At time of intervention, and at 6, 12,24, and 36 months
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At time of intervention, and at 6, 12,24, and 36 months
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Myocardial infarction
Časové okno: At time of intervention, and at 6, 12, 24, and 36 months
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At time of intervention, and at 6, 12, 24, and 36 months
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Ischemia driven target lesion revascularisation (TLR)
Časové okno: At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 24, and 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, 24, and 36 months
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Ischemia driven target vessel revascularisation (TVR)
Časové okno: at 6, 12, 24, and 36 month
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at 6, 12, 24, and 36 month
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In-lesion % diameter stenosis
Časové okno: Baseline and final at time of intervention and at 24 months FU
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QCA: Independent CoreLab
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Baseline and final at time of intervention and at 24 months FU
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Minimal lumen diameter (MLD)
Časové okno: Baseline and final at time of intervention and at 24 months FU
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QCA: Independent CoreLab
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Baseline and final at time of intervention and at 24 months FU
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In-scaffold late lumen loss (LLL)
Časové okno: At 24 months FU
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At 24 months FU
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Detlef G Mathey, Prof. Dr., Medical Care Center Prof. Mathey, Prof. Schofer GmbH
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Basavarajaiah S, Naganuma T, Latib A, Colombo A. Can bioabsorbable scaffolds be used in calcified lesions? Catheter Cardiovasc Interv. 2014 Jul 1;84(1):48-52. doi: 10.1002/ccd.24939. Epub 2013 Aug 31.
- Patel N, Banning AP. Bioabsorbable scaffolds for the treatment of obstructive coronary artery disease: the next revolution in coronary intervention? Heart. 2013 Sep;99(17):1236-43. doi: 10.1136/heartjnl-2012-303346. Epub 2013 Mar 8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ASSURE ROT
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