A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population

DK Medical Technology (Suzhou) Co., Ltd.15 sites in 1 country260 target enrollmentFebruary 22, 2018

ConditionsCoronary In-stent Restenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary In-stent Restenosis
Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Enrollment: 260
Locations: 15
Primary Endpoint: In-segment Late Lumen Loss
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.

Registry

clinicaltrials.gov

Start Date

February 22, 2018

End Date

April 24, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DK Medical Technology (Suzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Related to the patients:
•Age ≥18 years old
•Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
•Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
•Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
•Related to lesion:
•Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm
•Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
•The distance between other lesion requires interventional therapy and the target lesion must be \> 10mm
•One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation

Exclusion Criteria

•Related to patients
•Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
•Patients with cardiogenic shock
•The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation
•Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
•Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
•Patients with severe congestive heart failure or NYHA grade IV heart failure
•Patients with moderate or severe valvular heart disease
•Patients who had heart transplantation
•Patients with renal insufficiency (eGFR \< 30mL/min)

Outcomes

Primary Outcomes

In-segment Late Lumen Loss

Time Frame: From the end of procedure to 9 months after the procedure

In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.

Secondary Outcomes

Device success rate of the interventional therapy(From the start of index procedure to end of index procedure)
Lesion success rate of the interventional therapy(From the start of index procedure to end of index procedure)
Rate of restenosis in the target lesions(9 months after the procedure)
Target lesion failure (TLF) rate(9 months after the procedure)
Rate of major adverse cardiovascular events(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
TLR rate(9 months after the procedure)
Rate of all adverse events and severe adverse events(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
Clinical success rate of the interventional therapy(7 days after the procedure)
Target vessel revascularization (TVR) rate(9 months after the procedure)