Vulnerable PlaqueNCT02319733
Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold
A study testing Bioresorbable vascular scaffold in people with Vulnerable Plaque, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
Trial summary
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vulnerable Plaque
- What is being tested?
- Bioresorbable vascular scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Jan 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic patients between the age of 18 and 80 years
- Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
- Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
- FFR negative lesion at coronary angiogram
- Vessel diameter ≥2.5 mm on visual estimate
- GFR ≥ 45mL/min/1.73m².
Who cannot join
- High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
- Lesions located in a coronary vessels previously stented.
- Lesions located at a bifurcation
- lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
- the presence of thrombus or another clinically significant stenosis in the target vessel.
- Left main (>50%) or known three vessel disease.
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- Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction <30%
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
- Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
- History of stent thrombosis
- Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
- Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Canisuis Wilhelmina Hospital
Nijmegen, Gelderland, 6532 SZ
About this study
Official title: Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.
- Conditions
- Vulnerable Plaque
- Being tested
- Bioresorbable vascular scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable vascular scaffoldDevice
Implantation of Bioresorbable vascular scaffold in vulnerable plaques
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Implantation of Bioresorbable vascular scaffold in vulnerable plaques Receives: Device: Bioresorbable vascular scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in plaque cumulative score of signs of vulnerability on CT
Measured: 24 months
nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS
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 posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: insufficient eligable subjects and new data on BVS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulnerable PlaqueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.E.R. Gomes, Canisius-Wilhelmina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319733
- Sponsor's protocol ID
- 2013/498
- Status last verified
- Feb 2017
- First submitted
- 14 Dec 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients
- ClinicalTrials.gov ID
- NCT02319733
- Acronym / sponsor ID
- 2013/498
- Conditions
- Vulnerable Plaque
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient eligable subjects and new data on BVS
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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.
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Device: Bioresorbable vascular scaffoldImplantation of Bioresorbable vascular scaffold in vulnerable plaques |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic patients between the age of 18 and 80 years
- Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
- Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
- FFR negative lesion at coronary angiogram
- Vessel diameter ≥2.5 mm on visual estimate
Key exclusion criteria (12 listed)
- High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
- Lesions located in a coronary vessels previously stented.
- Lesions located at a bifurcation
- lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
- the presence of thrombus or another clinically significant stenosis in the target vessel.
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 |
|---|---|---|
| Bioresorbable vascular scaffoldImplantation of Bioresorbable vascular scaffold in vulnerable plaques | Device | Bioresorbable vascular scaffold |
Primary outcome
change in plaque cumulative score of signs of vulnerability on CT
Time frame: 24 months
nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS
Time frame: 24 months
Results and safety
The study was stopped early (reason given: insufficient eligable subjects and new data on BVS). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable vascular scaffold in people with Vulnerable Plaque, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 14 Feb 2017. 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 Netherlands. 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 was stopped early (reason given: insufficient eligable subjects and new data on BVS). Results are not available in the source record.
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?
change in plaque cumulative score of signs of vulnerability on CT (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2017.