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

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Brief Title

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

Official Title

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

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.

Study Type

Interventional

Primary Outcome

time to disease progression

Condition

Kawasaki Disease

Intervention

Bioresorbable Vascular Scaffold

Study Arms / Comparison Groups

 Kawasaki disease
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

10

Start Date

February 2016

Completion Date

February 2019

Primary Completion Date

February 2019

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

Ages

10 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Wang Yi-Chih, 886-972652218, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT02771288

Organization ID

201512126DINC

Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital

Study Sponsor

Wang Yi-Chih, Principal Investigator, NTUH

Verification Date

May 2016