NCT04265989

Brief Summary

This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

February 10, 2020

Last Update Submit

February 12, 2020

Conditions

Coronary Artery Ectasia

Keywords

coronary artery ectasianew classificationinterventional therapycoronary artery aneurysm

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac and cerebral events (MACCEs)

    Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization

    6 months after treatment

Secondary Outcomes (3)

  • Changes in CCS grade

    6 months after treatment

  • Changes in drug use

    6 months after treatment

  • Changes in coronary artery aneurysm diameter

    6 months after treatment

Study Arms (4)

coronary artery aneurysm with branches

EXPERIMENTAL

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm

Device: Single BMS

coronary artery aneurysm without branches

EXPERIMENTAL

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm

Device: Single or Double BMS

Coronary artery aneurysm with localized stenosis

EXPERIMENTAL

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. localized stenosis defined as lesion to more than 70% stenosis and length less than 20 mm

Device: Single or Double BMS

Coronary artery aneurysm with diffuse stenosis

EXPERIMENTAL

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. Diffuse stenosis defined as lesion to more than 70% and length more than 20 mm

Device: BMS+DES

Interventions

Single BMSDEVICE

Single bare metal stent covered the coronary artery aneurysm

coronary artery aneurysm with branches
Single or Double BMSDEVICE

Single or double layer bare metal stents covered the coronary artery aneurysm

coronary artery aneurysm without branches
BMS+DESDEVICE

Treated with bare metal stent combined with drug eluting stent

Coronary artery aneurysm with diffuse stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female aged ≥18 years;
  • Coronary artery ectasia was confirmed by coronary CT or coronary angiography;
  • The patient (or guardian) is fully aware of the study process and signs the informed consent;
  • Patients were able to undergo subsequent follow-up.

You may not qualify if:

  • Congenital coronary artery fistula;
  • kawasaki disease;
  • Treponema pallidum or lyme treponema;
  • Marfan;
  • Primary lymphoma;
  • Coronary artery pseudoaneurysm;
  • Acute infectious disease or autoimmune disease;
  • Hematological Disease;
  • Severe liver and kidney dysfunction (AMI one week later, alanine transaminase ≥3 times the upper limit of normal value; Creatinine clearance rate ≤30ml/min or blood creatinine ≥2.5mg/dl);
  • Unstable craniocerebral disease;
  • Cancer;
  • Severe cognitive impairment (dementia or severe mental illness);
  • Patients with severe physical disabilities who cannot be followed up regularly;
  • Other serious uncontrolled systemic diseases;
  • Female patient who is ready to become pregnant, already pregnant or nursing;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Study Officials

  • Shubin Qiao, MD,PhD

    Fuwai Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shubin Qiao, MD,PhD

CONTACT

+8613701237893qsbfw@sina.com

Zhuoxuan Yang, MD,PhD

CONTACT

+8618811756722525599492@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Head of cardiology department

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

November 1, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CN(1)