NCT03079934

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

March 11, 2016

Last Update Submit

August 7, 2018

Conditions

Coronary Heart Disease

Keywords

Bioresorbable vascular scaffoldOptical coherence tomographystrut coverageacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • the amount of tissue coverage per strut level analysis at OCT

    according to study protocol

    7 weeks

Secondary Outcomes (6)

  • amount of diameter stenosis per strut in OCT examination

    7 weeks

  • amount of diameter stenosis per strut in OCT examination

    24 months

  • healing score in OCT examination

    7 weeks

  • healing score in OCT examination

    24 months

  • proportion of malapposed and protruding struts per stent in OCT examination

    7 weeks

  • +1 more secondary outcomes

Study Arms (1)

Absorb-BVS

Bioresorbable vascular scaffold implantation

Device: Absorb-BVS

Interventions

Absorb-BVSDEVICE

BVS patients undergoing optical coherence tomography examination at follow-up

Also known as: Absorb
Absorb-BVS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data of patients who undergo OCT examination at different time points after BVS implantation will be analysed.

You may qualify if:

  • optical coherence tomography examination after BVS-implantation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munich University Clinic

Munich, Bavarian, 81377, Germany

Location

Related 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):16-23. doi: 10.1111/joic.12359. Epub 2016 Nov 28.

    PMID: 27896843RESULT

MeSH Terms

Conditions

Coronary DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Julinda Mehilli, MD

    Munich University Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Interventional cardiology

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 15, 2017

Study Start

May 1, 2013

Primary Completion

July 1, 2016

Study Completion

September 20, 2016

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)