A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease in Chinese Population

DK Medical Technology (Suzhou) Co., Ltd.15 sites in 1 country277 target enrollmentJune 20, 2018

ConditionsCoronary Small Vessel Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Small Vessel Disease
Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Enrollment: 277
Locations: 15
Primary Endpoint: In-segment percent diameter stenosis of the target lesion at 9 months after procedure
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 in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.

Registry

clinicaltrials.gov

Start Date

June 20, 2018

End Date

April 15, 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:
•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 (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
•Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
•Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and
•Patients who can receive balloon angioplasty
•Related to lesion:
•The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
•Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
•One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES)

Exclusion Criteria

•Related to patients
•Patients who had Myocardial Infarction within 1 week before being included
•Patients with severe congestive heart failure or NYHA grade IV heart failure
•Left ventricular ejection fraction (LVEF) \< 35%
•Patients who had heart transplantation
•Patients with severe valvular heart disease
•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 with leukopenia (white blood cell count \< 3×10\^9/L) for more than three days; Patients with low neutrophil counts (ANC \< 1000/mm\^3) for more than three days; Patients with thrombocytopenia (platelet count \< 100,000/mm\^3)
•Patients with renal insufficiency (eGFR \< 30mL/min)
•Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel

Outcomes

Primary Outcomes

In-segment percent diameter stenosis of the target lesion at 9 months after procedure

Time Frame: 9 months after the procedure

Secondary Outcomes

Binary restenosis rate in lesion section(9 months after the procedure)
Target vessel revascularization (TVR) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
Target lesion failure (TLF) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)
Lesion success rate of the interventional therapy(From the start of index procedure to the end of index procedure, Day 0)
In-device late lumen loss (LLL)(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)
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)
In-device percent diameter stenosis of the target lesion(9 months after the procedure)
In-segment MLD(9 months after the procedure)
Device success rate of the interventional therapy(From the start of index procedure to the end of index procedure, Day 0)
Clinical success rate of the interventional therapy(7 days after the procedure)
In-device minimal lumen diameter (MLD)(9 months after the procedure)
In-segment LLL(9 months after the procedure)
Target lesion revascularization (TLR) rate(1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure)