Vascular Healing After BVS-implantation

NCT ID: NCT03079934

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-09-20

Brief Summary

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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

Detailed Description

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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.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Absorb-BVS

Bioresorbable vascular scaffold implantation

Absorb-BVS

Intervention Type DEVICE

BVS patients undergoing optical coherence tomography examination at follow-up

Interventions

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Absorb-BVS

BVS patients undergoing optical coherence tomography examination at follow-up

Intervention Type DEVICE

Other Intervention Names

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Absorb

Eligibility Criteria

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Inclusion Criteria

* optical coherence tomography examination after BVS-implantation

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role collaborator

LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Julinda Mehilli

Director, Interventional cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julinda Mehilli, MD

Role: STUDY_CHAIR

Munich University Clinic

Locations

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Munich University Clinic

Munich, Bavarian, Germany

Site Status

Countries

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Germany

References

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Baquet M, Brenner C, Wenzler M, Eickhoff M, David J, Brunner S, Theiss H, Massberg S, Guagliumi G, Mehilli J. Impact of Clinical Presentation on Early Vascular Healing After Bioresorbable Vascular Scaffold Implantation. J Interv Cardiol. 2017 Feb;30(1):16-23. doi: 10.1111/joic.12359. Epub 2016 Nov 28.

Reference Type RESULT
PMID: 27896843 (View on PubMed)

Other Identifiers

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MucC002-14

Identifier Type: -

Identifier Source: org_study_id

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