NCIPCAE: A New Classification and Interventional Therapy for Coronary Artery Ectasia

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Unknown status

CT.gov ID

NCT04265989

Collaborator

Beijing Chao Yang Hospital (Other), Peking University People's Hospital (Other), Hebei Medical University Fourth Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Ectasia	Device: Single BMS Device: Single or Double BMS Device: Single or Double BMS Device: BMS+DES	N/A

Detailed Description

Coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. Clinical symptoms include angina, myocardial infarction and sudden death.At present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.Most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.As a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.By comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.The purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A New Classification and Interventional Therapy for Coronary Artery Ectasia

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: coronary artery aneurysm with branches The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm	Device: Single BMS Single bare metal stent covered the coronary artery aneurysm
Experimental: coronary artery aneurysm without branches 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 Single or double layer bare metal stents covered the coronary artery aneurysm
Experimental: Coronary artery aneurysm with localized stenosis 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 Treated with single or double layer bare metal stents
Experimental: Coronary artery aneurysm with diffuse stenosis 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 Treated with bare metal stent combined with drug eluting stent

Outcome Measures

Primary Outcome Measures

Major adverse cardiac and cerebral events (MACCEs) [6 months after treatment]
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization

Secondary Outcome Measures

Changes in CCS grade [6 months after treatment]
Number of participants with CCS angina pectoris grade aggravated or alleviate
Changes in drug use [6 months after treatment]
Number of participants with increased the type or dose of anti-myocardial ischemia drugs
Changes in coronary artery aneurysm diameter [6 months after treatment]
Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Contraindications to percutaneous coronary intervention (PCI) : for patients at high risk of massive bleeding in the digestive tract, intracranial and other areas, or allergic to contrast agents;
Cannot tolerate dual antiplatelet therapy for at least 1 year;
Age < 18 years old;
Patients who are unable or unwilling to sign informed consent