Coronary Heart DiseaseNCT03079934
Vascular Healing After BVS-implantation
An observational study of Coronary Heart Disease, run by LMU Klinikum at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Absorb-BVS
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to 20 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of patients who undergo OCT examination at different time points after BVS implantation will be analysed.
Who may be able to join
- optical coherence tomography examination after BVS-implantation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Absorb-BVS
- Keywords
- Bioresorbable vascular scaffold, Optical coherence tomography, strut coverage, acute coronary syndrome
- Medical subject headings
- Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb-BVSDevice
Also called Absorb
BVS patients undergoing optical coherence tomography examination at follow-up
| Study group | Role | What they receive |
|---|---|---|
| Absorb-BVS | Bioresorbable vascular scaffold implantation Receives: Device: Absorb-BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of tissue coverage per strut level analysis at OCT
according to study protocol
Measured: 7 weeks
Secondary outcomes (6)
amount of diameter stenosis per strut in OCT examination
according to study protocol
Measured: 7 weeks
amount of diameter stenosis per strut in OCT examination
according to study protocol
Measured: 24 months
healing score in OCT examination
according to study protocol
Measured: 7 weeks
healing score in OCT examination
according to study protocol
Measured: 24 months
proportion of malapposed and protruding struts per stent in OCT examination
according to study protocol
Measured: 7 weeks
proportion of malapposed and protruding struts per stent in OCT examination
according to study protocol
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startMay 2013
- Primary completionJul 2016
- Study completion20 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Prof. Dr. Julinda Mehilli, LMU Klinikum
- Investigators
- Julinda Mehilli, MD, Study chair, Munich University Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079934
- Sponsor's protocol ID
- MucC002-14
- Status last verified
- Aug 2018
- First submitted
- 11 Mar 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27896843
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Healing After Implantation of Bioresorbable Vascular Scaffold in Different Clinical Settings and Follow-up Time Points
- ClinicalTrials.gov ID
- NCT03079934
- Acronym / sponsor ID
- MucC002-14
- Conditions
- Coronary Heart Disease
- Keywords
- Bioresorbable vascular scaffold, Optical coherence tomography, strut coverage, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absorb-BVS | – | Device: Absorb-BVSBioresorbable vascular scaffold implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of patients who undergo OCT examination at different time points after BVS implantation will be analysed.
Key inclusion criteria (1 listed)
- optical coherence tomography examination after BVS-implantation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorb-BVSAlso: AbsorbBVS patients undergoing optical coherence tomography examination at follow-up | Device | Absorb-BVS |
Primary outcome
the amount of tissue coverage per strut level analysis at OCT
Time frame: 7 weeks
according to study protocol
6 secondary outcomes
amount of diameter stenosis per strut in OCT examination
Time frame: 7 weeks
amount of diameter stenosis per strut in OCT examination
Time frame: 24 months
healing score in OCT examination
Time frame: 7 weeks
healing score in OCT examination
Time frame: 24 months
proportion of malapposed and protruding struts per stent in OCT examination
Time frame: 7 weeks
proportion of malapposed and protruding struts per stent in OCT examination
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Results publication: PubMed 27896843Baquet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julinda Mehilli, MD study chair
Munich University Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of tissue coverage per strut level analysis at OCT (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.