Kawasaki DiseaseNCT02771288
Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.
A study testing Bioresorbable Vascular Scaffold in people with Kawasaki Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD). Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Kawasaki Disease
- 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
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2016to Feb 2019
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- In the single-group prospective study with safety and imaging endpoints, a total of 10 KD patients < 18 years will be enrolled.
- The diagnosis of KD was made based on clinical criteria for KD.
Who cannot join
- Patients presenting with an acute myocardial infarction or unstable arrhythmias, or those who has severe left ventricular dysfunction (ejection fraction less than 35%), intrastent restenotic lesions, lesions located in the left main coronary artery, and tight lesions which could not be well dilated even after rotational atherectomy are excluded. Those with chronic renal insufficiency (creatinine >1.5 mg/dl) are also excluded due to the limitation of OCT (optical coherence tomography) use.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, test3
Wang Yi-Chih, 886-972652218, med011@seed.net.tw
About this study
Official title: Safety and Vascular Remodelling After Bioresorbable Vascular Scaffold Implantation for Stenotic or Occluded Lesions in Children and Young Adults With Kawasaki Disease
To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD).
Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing a clinically significant stenotic lesion during follow-up. They are at risk of myocardial infarction-related sudden death or congestive heart failure as young adults. Bypass surgery could be the reasonable strategy but the long-term patency of the graft remains unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the alternative. However, metallic stenting remains problematic in several aspects mainly due to the restriction of vessel expansive remodeling. The novel BVS has the potential to be free from the limitation due to scaffold degradation.
Read the detailed description
we will conduct a single-center, single-group prospective study with safety and imaging endpoints. A total of 10 KD children or young adults with indication of revascularization are enrolled, and BVS will be implanted for stenotic or occluded lesions. QCA and optical coherence tomography (OCT) are used to evaluate the baseline lumen area, plaque characteristics, and BVS expansion or eccentricity after deployment. At 12 months, scaffold restenosis is evaluated by multislice computed tomography. At 30 months, patients will receive follow-up by angiography and OCT to evaluate lumen area, neoplaque characteristics, and side branch conditions. Otherwise, the composite endpoint including cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation are assessed at 30 days, 6 and 9 months, and 1, 2, 3 years.
- Conditions
- Kawasaki Disease
- Being tested
- Bioresorbable Vascular Scaffold
- Keywords
- Kawasaki disease, optical coherence tomography, multislice computed tomography
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable Vascular ScaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| Kawasaki disease | Other | Not described Receives: Device: Bioresorbable Vascular Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to disease progression
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Yi-Chih, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771288
- Sponsor's protocol ID
- 201512126DINC
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Vascular Remodelling After Bioresorbable Vascular Scaffold Implantation for Stenotic or Occluded Lesions in Children and Young Adults With Kawasaki Disease
- ClinicalTrials.gov ID
- NCT02771288
- Acronym / sponsor ID
- 201512126DINC
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease, optical coherence tomography, multislice computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 13 May 2016 (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.
To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD).
Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing a clinically significant stenotic lesion during follow-up. They are at risk of myocardial infarction-related sudden death or congestive heart failure as young adults. Bypass surgery could be the reasonable strategy but the long-term patency of the graft remains unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the alternative. However, metallic stenting remains problematic in several aspects mainly due to the restriction of vessel expansive remodeling. The novel BVS has the potential to be free from the limitation due to scaffold degradation.
Detailed description
we will conduct a single-center, single-group prospective study with safety and imaging endpoints. A total of 10 KD children or young adults with indication of revascularization are enrolled, and BVS will be implanted for stenotic or occluded lesions. QCA and optical coherence tomography (OCT) are used to evaluate the baseline lumen area, plaque characteristics, and BVS expansion or eccentricity after deployment. At 12 months, scaffold restenosis is evaluated by multislice computed tomography. At 30 months, patients will receive follow-up by angiography and OCT to evaluate lumen area, neoplaque characteristics, and side branch conditions. Otherwise, the composite endpoint including cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation are assessed at 30 days, 6 and 9 months, and 1, 2, 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kawasaki disease | Other | Device: Bioresorbable Vascular Scaffold |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- In the single-group prospective study with safety and imaging endpoints, a total of 10 KD patients < 18 years will be enrolled.
- The diagnosis of KD was made based on clinical criteria for KD.
Key exclusion criteria (1 listed)
- Patients presenting with an acute myocardial infarction or unstable arrhythmias, or those who has severe left ventricular dysfunction (ejection fraction less than 35%), intrastent restenotic lesions, lesions located in the left main coronary artery, and tight lesions which could not be well dilated even after rotational atherectomy are excluded. Those with chronic renal insufficiency (creatinine >1.5 mg/dl) are also excluded due to the limitation of OCT (optical coherence tomography) use.
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 Scaffold | Device | Kawasaki disease |
Primary outcome
time to disease progression
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- 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.
Wang Yi-Chih principal investigator
NTUH
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 Kawasaki Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 25 May 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Yi-Chih (886-972652218, med011@seed.net.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to disease progression (time frame: up to 12 months). 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 25 May 2016.