A Randomized, Multicenter Study on the Efficacy and Safety of Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) Compared to POBA in the Treatment of Small Vessel Disease (SVD) Patient

B. Braun Medical International Trading Company Ltd.1 site in 1 country270 target enrollmentDecember 18, 2017

ConditionsSmall Vessel Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Small Vessel Disease
Sponsor: B. Braun Medical International Trading Company Ltd.
Enrollment: 270
Locations: 1
Primary Endpoint: Late lumen loss in segment section at M9
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.

Registry

clinicaltrials.gov

Start Date

December 18, 2017

End Date

December 30, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

B. Braun Medical International Trading Company Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Criteria related to subjects
•Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or documented silent ischemia;
•At the age of 18-80;
•Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the study. Hence, patients will be advised to use an adequate birth control method up to (including) the end of follow-up;
•Patients must agree to undergo the 9-month angiographic follow-up and the clinical follow-up at 30 days, 6 months, 9 months and 12 months after operation;
•Patients who are psychologically and linguistically able to understand the purpose of the study, and show sufficient compliance with the study protocol;
•Patients who have expressed acknowledgment of the risks and benefits described in the informed consent document by providing informed consent;
•Criteria related to lesions
•The target lesion is primary, in situ coronary artery lesion located in 1 or 2 different coronary arteries, with no more than 1 target lesion in each coronary artery;
•The reference vessel diameter is within the range of 2.0 mm - 2.75 mm; (visually measured)

Exclusion Criteria

•Criteria related to subjects
•Patients with recent myocardial infarction (within one week), or patients with myocardial infarction over one week but whose troponin level has not recovered to normal;
•Patients with severe congestive heart failure or NYHA class IV heart failure;
•Patients with severe valvular heart disease;
•Women who are pregnant or lactating;
•Patients with remaining life expectancy of no more than 1 year or with factors causing difficulty in clinical follow-up;
•Patients who had cerebral stroke within 6 months before operation;
•Patients who are currently involved in any other clinical trial;
•Patients with presence or history of severe hepatic failure and therefore are not eligible for angiography;
•Patients with presence or history of severe renal failure (GFR \< 30 ml/min) and therefore are not eligible for angiography;