Vascular Healing After BVS-implantation

August 7, 2018 updated by: Prof. Dr. Julinda Mehilli, LMU Klinikum

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavarian
      • Munich, Bavarian, Germany, 81377
        • Munich University Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • optical coherence tomography examination after BVS-implantation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Absorb-BVS
Bioresorbable vascular scaffold implantation
Device: Absorb-BVS
BVS patients undergoing optical coherence tomography examination at follow-up
Other Names:
  • Absorb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the amount of tissue coverage per strut level analysis at OCT
Time Frame: 7 weeks
according to study protocol
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of diameter stenosis per strut in OCT examination
Time Frame: 7 weeks
according to study protocol
7 weeks
amount of diameter stenosis per strut in OCT examination
Time Frame: 24 months
according to study protocol
24 months
healing score in OCT examination
Time Frame: 7 weeks
according to study protocol
7 weeks
healing score in OCT examination
Time Frame: 24 months
according to study protocol
24 months
proportion of malapposed and protruding struts per stent in OCT examination
Time Frame: 7 weeks
according to study protocol
7 weeks
proportion of malapposed and protruding struts per stent in OCT examination
Time Frame: 24 months
according to study protocol
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

  • Study Chair: Julinda Mehilli, MD, Munich University Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

September 20, 2016

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 8, 2017

First Posted (ACTUAL)

March 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MucC002-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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