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

NCT02771288 | Unknown DMC

• 1 other identifier: 201512126DINC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Kawasaki Disease

Keywords

Kawasaki disease; optical coherence tomography; multislice computed tomography

Outcome Measures

Primary Outcomes (1)

• time to disease progression

  up to 12 months

Study Arms (1)

Kawasaki disease

OTHER

Device: Bioresorbable Vascular Scaffold

Interventions

Bioresorbable Vascular Scaffold DEVICE

Kawasaki disease

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wang Yi-Chih

  NTUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Yi-Chih

CONTACT

886-972652218; med011@seed.net.tw

Hsiao Ya-Yun

CONTACT

886-978377116; hsiao716@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 13, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)