Tomography, Optical Coherence Clinical Trial
— INVESTOfficial title:
Mechanisms of Very Late Bioresorbable Scaffold Thrombosis Assessed by Optical Coherence Tomography: Insights From the International INVEST Registry
Verified date | October 2017 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE
mark) and is used in daily clinical practice. While recent randomized controlled trials
comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable
device thrombosis after BVS implantation, the causes underlying thrombotic events occurring
beyond one year after scaffold implantation remain unclear and require investigation in an
independent manner.
The INVEST registry is a world-wide, multi-center, observational, retrospective,
investigator-initiated registry, which will include any patients who suffered from very late
(>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of
thrombosis and provided informed consent for the further use of their health related data for
this registry.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 25, 2017 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Any patients who suffered from scaffold thrombosis occurring beyond 1 year after implantation of a Absorb BVS 1.1 and investigated by OCT at the timepoint of thrombosis. 2. Sufficient quality of the OCT recording allowing for CoreLab analysis. Exclusion Criteria: - No exclusion criteria will be applied. |
Country | Name | City | State |
---|---|---|---|
Austria | 5th Medical Department with Cardiology, Kaiser Franz Josef Hospital | Vienna | |
Belgium | Department of Cardiology, University Hospital Leuven | Leuven | |
France | Cardiology Department, CHU Clermont-Ferrand | Clermont-Ferrand | |
France | Department of Cardiology, University Hospital Caremeau | Nimes | |
France | Department of Cardiology, CH F Mitterand, Pau Université Cedex, France. | Pau | |
France | Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Lab (Hi-Lab) Clinique Pasteur | Toulouse | |
Germany | Department of Cardiology, University of Giessen | Giessen | |
Germany | Department of Cardiology, Asklepios Klinik St. Georg | Hamburg | |
Germany | Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel | Kiel | |
Germany | Deutsches Herzzentrum München, Technische Universität München, | Munich | |
Hong Kong | Cardiology Division, Department of Medicine, Pamela Youde Nethersole Eastern Hospital | Chai Wan | |
Hong Kong | Cardiology Division, Department of Medicine, Queen Elizabeth Hospital | Kowloon | |
Italy | Cardiology Division, Bolognini Hospital | Seriate | |
Netherlands | Academic Medical Center, University of Amsterdam | Amsterdam | |
Netherlands | Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. | Rotterdam | |
Netherlands | Department of Cardiology, University Medical Centre Utrecht | Utrecht | |
Singapore | Cardiac Department, National University Heart Centre | Singapore | |
Spain | Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain. | Barcelona | |
Switzerland | Department of Cardiology, Stadtspital Triemli | Zurich |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Austria, Belgium, France, Germany, Hong Kong, Italy, Netherlands, Singapore, Spain, Switzerland,
de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998 Aug;19(8):1214-23. — View Citation
Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1. — View Citation
Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Igarashi K, Kozuma K, Tanabe K, Kusano H, Rapoza R, Popma JJ, Stone GW, Simonton C, Serruys PW, Kimura T. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016 Oct 20;12(9):1090-1101. doi: 10.4244/EIJY16M09_01. — View Citation
Räber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabaté M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015 Oct 27;66(17):1901-14. doi: 10.1016/j.jacc.2015.08.853. — View Citation
Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrié D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iñiguez A, Sabaté M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30. — View Citation
Taniwaki M, Radu MD, Zaugg S, Amabile N, Garcia-Garcia HM, Yamaji K, Jørgensen E, Kelbæk H, Pilgrim T, Caussin C, Zanchin T, Veugeois A, Abildgaard U, Jüni P, Cook S, Koskinas KC, Windecker S, Räber L. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography. Circulation. 2016 Feb 16;133(7):650-60. doi: 10.1161/CIRCULATIONAHA.115.019071. Epub 2016 Jan 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Underlying main reason for stent thrombosis | Underlying main reason for stent thrombosis per expert panel consensus | Baseline |
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