A New Classification and Interventional Therapy for Coronary Artery Ectasia

NCT ID: NCT04265989

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-11-30

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.

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.

Conditions

Coronary Artery Ectasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Single BMS

Intervention Type: DEVICE

Single bare metal stent covered the coronary artery aneurysm

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

Group Type: EXPERIMENTAL

Single or Double BMS

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

Single or Double BMS

Intervention Type: DEVICE

Treated with single or double layer bare metal stents

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

Group Type: EXPERIMENTAL

BMS+DES

Intervention Type: DEVICE

Treated with bare metal stent combined with drug eluting stent

Interventions

Single BMS

Single bare metal stent covered the coronary artery aneurysm

Intervention Type: DEVICE

Single or Double BMS

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

Intervention Type: DEVICE

Single or Double BMS

Treated with single or double layer bare metal stents

Intervention Type: DEVICE

BMS+DES

Treated with bare metal stent combined with drug eluting stent

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shubin_Qiao

Director,Head of cardiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shubin Qiao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Beijing, China

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shubin Qiao, MD,PhD

Role: CONTACT

qsbfw@sina.com

+8613701237893

Zhuoxuan Yang, MD,PhD

Role: CONTACT

525599492@qq.com

+8618811756722

Facility Contacts

Shubin Qiao, MD,PhD

Role: primary

qsbfw@sina.com

+8613001237893

Zhuoxuan Yang, MD,PhD

Role: backup

525599492@qq.com

+8618811756722

Other Identifiers

2019XK320064

Identifier Type: -

Identifier Source: org_study_id