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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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

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Kawasaki Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Kawasaki disease

Group Type OTHER

Bioresorbable Vascular Scaffold

Intervention Type DEVICE

Interventions

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Bioresorbable Vascular Scaffold

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No