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OpenTrials
Completed

NCT Number: NCT03079934

Vascular Healing After BVS-implantation

Evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging.

In addition long-term clinical follow-ups are planned for all patients treated with Absorb in the institution

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Key information

Conditions

Coronary Heart Disease Acute Coronary Syndrome Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Munich University Clinic

Munich, Bavarian, 81377, Germany

About this study

OCT-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. These results will be analysed in terms of clinical presentation, gender and age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • optical coherence tomography examination after BVS-implantation

Exclusion criteria

  • None

Treatment and study plan

Absorb-BVS

Device

BVS patients undergoing optical coherence tomography examination at follow-up

Other names: Absorb

Primary outcomes

  1. the amount of tissue coverage per strut level analysis at OCT

    Time frame: 7 weeks

    according to study protocol

Secondary outcomes

  1. amount of diameter stenosis per strut in OCT examination

    Time frame: 7 weeks

    according to study protocol

  2. amount of diameter stenosis per strut in OCT examination

    Time frame: 24 months

    according to study protocol

  3. healing score in OCT examination

    Time frame: 7 weeks

    according to study protocol

  4. healing score in OCT examination

    Time frame: 24 months

    according to study protocol

  5. proportion of malapposed and protruding struts per stent in OCT examination

    Time frame: 7 weeks

    according to study protocol

  6. proportion of malapposed and protruding struts per stent in OCT examination

    Time frame: 24 months

    according to study protocol

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

Vascular Healing After Implantation of Bioresorbable Vascular Scaffold in Different Clinical Settings and Follow-up Time Points

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2017
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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