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

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

Sponsors

Lead Sponsor: National Taiwan University Hospital

Source National Taiwan University Hospital
Brief 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.

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.

Overall Status Unknown status
Start Date February 2016
Completion Date February 2019
Primary Completion Date February 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
time to disease progression up to 12 months
Enrollment 10
Condition
Intervention

Intervention Type: Device

Intervention Name: Bioresorbable Vascular Scaffold

Arm Group Label: Kawasaki disease

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wang Yi-Chih Principal Investigator NTUH
Overall Contact

Last Name: Wang Yi-Chih

Phone: 886-972652218

Email: [email protected]

Location
Facility: Status: Contact: National Taiwan University Hospital Wang Yi-Chih 886-972652218 [email protected]
Location Countries

Taiwan

Verification Date

May 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Kawasaki disease

Type: Other

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov