Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial

Chinese PLA General Hospital0 sites140 target enrollmentJuly 15, 2018

ConditionsDiffuse Coronary Artery Lesions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diffuse Coronary Artery Lesions
Sponsor: Chinese PLA General Hospital
Enrollment: 140
Primary Endpoint: Late lumen loss
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.

Registry

clinicaltrials.gov

Start Date

July 15, 2018

End Date

June 30, 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Yun Dai Chen

Professor

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

•Patient-related
•Patients who have typical angina pectoris symptoms with obvious evidence of ischemia;
•Patients whose ages are between 18-80 years;
•Patients who must agree to receive a 9-month angiographic follow-up;
•Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months;
•Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol;
•Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent;
•Lesion-related
•Diffuse coronary artery disease in situ;
•Reference target vessel diameter of 2.5-4.0 mm and length of \> 25 mm;

Exclusion Criteria

•Patient-related:
•Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week;
•Patients with serious congestive heart failure or NYHA IV-level serious heart failure;
•Patients whose left ventricular ejection fraction is \< 30%;
•Patients who have medical history of stroke or TIA within 6 months prior to the surgery;
•Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography;
•Patients who have a current or previous history of serious kidney failure (GFR\<30 ml/min) and thereby fail to meet the requirements of angiography;
•Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage;
•Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically;
•Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists;