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Vascular Healing After BVS-implantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03079934
Enrollment
26
Registered
2017-03-15
Start date
2013-05-31
Completion date
2016-09-20
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Bioresorbable vascular scaffold, Optical coherence tomography, strut coverage, acute coronary syndrome

Brief summary

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

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.

Interventions

DEVICEAbsorb-BVS

BVS patients undergoing optical coherence tomography examination at follow-up

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
CollaboratorOTHER
LMU Klinikum
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* optical coherence tomography examination after BVS-implantation

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
the amount of tissue coverage per strut level analysis at OCT7 weeksaccording to study protocol

Secondary

MeasureTime frameDescription
amount of diameter stenosis per strut in OCT examination7 weeksaccording to study protocol
healing score in OCT examination7 weeksaccording to study protocol
proportion of malapposed and protruding struts per stent in OCT examination7 weeksaccording to study protocol

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026