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Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis

NCT03180931 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2017-10-30

No results posted yet for this study

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

Interventions

DEVICE

Bioresorbable vascular scaffold

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Lorenz Räber, MD, PhD · Bern University Hospital

  • Stephan Windecker, MD · Bern University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-02
Primary Completion
2017-05-31
Completion
2017-07-25
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180931 on ClinicalTrials.gov