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NCT03079934 Clinical Trial

Vascular Healing After BVS-implantation

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03079934
Other study ID # MucC002-14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2013
Est. completion date September 20, 2016

Study information
Verified date August 2018
Source Klinikum der Universitaet Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 20, 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- optical coherence tomography examination after BVS-implantation

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Absorb-BVS
BVS patients undergoing optical coherence tomography examination at follow-up

Locations
Country Name City State
Germany Munich University Clinic Munich Bavarian

Sponsors (2)
Lead Sponsor Collaborator
Klinikum der Universitaet Muenchen Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary the amount of tissue coverage per strut level analysis at OCT according to study protocol 7 weeks
Secondary amount of diameter stenosis per strut in OCT examination according to study protocol 7 weeks
Secondary amount of diameter stenosis per strut in OCT examination according to study protocol 24 months
Secondary healing score in OCT examination according to study protocol 7 weeks
Secondary healing score in OCT examination according to study protocol 24 months
Secondary proportion of malapposed and protruding struts per stent in OCT examination according to study protocol 7 weeks
Secondary proportion of malapposed and protruding struts per stent in OCT examination according to study protocol 24 months
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