Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis

NCT03180931 | Completed FDA Device

• 1 other identifier: INVEST
• Study Type: observational
• Target: 36
• Locations: 10 countries
• Sites: 19

Brief Summary

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.

Conditions

Coronary Thrombosis; Tomography, Optical Coherence; Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• Underlying main reason for stent thrombosis

  Underlying main reason for stent thrombosis per expert panel consensus

  Baseline

Study Arms (1)

Scaffold thrombosis

Any patients who suffered from scaffold thrombosis occurring beyond 1 year after implantation of a Absorb BVS 1.1 and investigated by OCT with sufficient image quality allowing for CoreLab analysis at the timepoint of thrombosis.

Device: Bioresorbable vascular scaffold

Interventions

Bioresorbable vascular scaffold DEVICE

No study specific procedures will be applied. Optical coherence tomography recordings at the time of very late scaffold thrombosis were obtained during clinical routine with one of the commercially available and approved optical coherence tomography consoles and catheters. The analysis will be conducted at the Core laboratory at Bern University Hospital, Bern, Switzerland using a systematic and validated approach. Every participant will be coded by getting a number (pseudonym) in the local institutes. In the Core Laboratory, data will be further coded to ensure anonymity of the participants.

Scaffold thrombosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From the hospital records, any patients who fulfill the inclusion criteria will be retrospectively included in the study. To estimate the denominator, total number of patients who underwent Absorb BVS implantation will also be collected.

You may qualify if:

• 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.
• Sufficient quality of the OCT recording allowing for CoreLab analysis.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (19)

5th Medical Department with Cardiology, Kaiser Franz Josef Hospital

Vienna, Austria

Location

Department of Cardiology, University Hospital Leuven

Leuven, Belgium

Location

Cardiology Department, CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Department of Cardiology, University Hospital Caremeau

Nîmes, France

Location

Department of Cardiology, CH F Mitterand, Pau Université Cedex, France.

Pau, France

Location

Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Lab (Hi-Lab) Clinique Pasteur

Toulouse, France

Location

Department of Cardiology, University of Giessen

Giessen, Germany

Location

Department of Cardiology, Asklepios Klinik St. Georg

Hamburg, Germany

Location

Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel

Kiel, Germany

Location

Deutsches Herzzentrum München, Technische Universität München,

Munich, Germany

Location

Cardiology Division, Department of Medicine, Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Location

Cardiology Division, Department of Medicine, Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

Cardiology Division, Bolognini Hospital

Seriate, Italy

Location

Academic Medical Center, University of Amsterdam

Amsterdam, Netherlands

Location

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Rotterdam, Netherlands

Location

Department of Cardiology, University Medical Centre Utrecht

Utrecht, Netherlands

Location

Cardiac Department, National University Heart Centre

Singapore, Singapore

Location

Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain.

Barcelona, Spain

Location

Department of Cardiology, Stadtspital Triemli

Zurich, Switzerland

Location

Related Publications (7)

• Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iniguez A, Sabate 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.

  PMID: 27806897 BACKGROUND

• 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.

  PMID: 26330419 BACKGROUND

• 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.

  PMID: 27597270 BACKGROUND

• Raber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabate 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.

  PMID: 26493663 BACKGROUND

• 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. doi: 10.1053/euhj.1998.1012.

  PMID: 9740343 BACKGROUND

• Taniwaki M, Radu MD, Zaugg S, Amabile N, Garcia-Garcia HM, Yamaji K, Jorgensen E, Kelbaek H, Pilgrim T, Caussin C, Zanchin T, Veugeois A, Abildgaard U, Juni P, Cook S, Koskinas KC, Windecker S, Raber 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.

  PMID: 26762519 BACKGROUND

• Yamaji K, Ueki Y, Souteyrand G, Daemen J, Wiebe J, Nef H, Adriaenssens T, Loh JP, Lattuca B, Wykrzykowska JJ, Gomez-Lara J, Timmers L, Motreff P, Hoppmann P, Abdel-Wahab M, Byrne RA, Meincke F, Boeder N, Honton B, O'Sullivan CJ, Ielasi A, Delarche N, Christ G, Lee JKT, Lee M, Amabile N, Karagiannis A, Windecker S, Raber L. Mechanisms of Very Late Bioresorbable Scaffold Thrombosis: The INVEST Registry. J Am Coll Cardiol. 2017 Nov 7;70(19):2330-2344. doi: 10.1016/j.jacc.2017.09.014.

  PMID: 29096803 DERIVED

MeSH Terms

Conditions

Coronary Thrombosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Lorenz Räber, MD, PhD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 8, 2017
• Study Start: December 2, 2016
• Primary Completion: May 31, 2017
• Study Completion: July 25, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); BE (1); IT (1); FR (4); NL (3); DE (4); HK (2); SG (1); CH (1); AU (1)