Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.

Kawasaki Disease Clinical Trial

Official title:

Safety and Vascular Remodelling After Bioresorbable Vascular Scaffold Implantation for Stenotic or Occluded Lesions in Children and Young Adults With Kawasaki Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771288
• Other study ID #: 201512126DINC
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2016
• Last updated: May 23, 2016
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: May 2016
• Source: National Taiwan University Hospital
• Contact: Wang Yi-Chih
• Phone: 886-972652218
• Email: med011[@]seed.net.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion criteria:

1. In the single-group prospective study with safety and imaging endpoints, a total of 10 KD patients < 18 years will be enrolled.

2. The diagnosis of KD was made based on clinical criteria for KD.

Exclusion criteria:

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome
• Vascular Remodeling

Intervention

Device:
• Bioresorbable Vascular Scaffold

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Test2

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to disease progression		up to 12 months	No