A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)

ZhuHai Cardionovum Medical Device Co., Ltd.14 sites in 1 country242 target enrollmentMay 2016

ConditionsCoronary Restenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Restenosis
Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Enrollment: 242
Locations: 14
Primary Endpoint: In-segment late lumen loss of the target lesion
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

May 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ZhuHai Cardionovum Medical Device Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Related to the patients:
•Age ≥18 years old
•Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-
•Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
•Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
•Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
•Related to the diseases:
•Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time
•Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be ≥70%, or ≥50% with the evidence of ischemia.
•One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.

Exclusion Criteria

•Related to the patients:
•Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
•The patients are participating in any other clinical trials before reaching the primary endpoints.
•The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
•The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
•Patients with a history of leukopenia (white blood cell count \<3×109/L for more than 3 days) or neutropenia (ANC\<1000/mm3 for more than 3 days) or thrombocytopenia (platelet \<100,000/mm3)
•Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
•Patients with renal insufficiency (eGFR\<30mL/min)
•Patients who are known to be allergic to Paclitaxel
•Patients who had myocardial infarction within 1 week before being included

Outcomes

Primary Outcomes

In-segment late lumen loss of the target lesion

Time Frame: 9 months

Secondary Outcomes

Occurrence rate of major adverse cardiovascular events(1, 6, 9, and 12 months after the operation)
Target lesion failure (TLF) rate(1, 6, 9, and 12 months after the operation)
Occurrence rate of restenosis in the target lesions(9 months after the operation)
Target lesion revascularization (TLR) rate(1, 6, 9, and 12 months after the operation)
Target vessel revascularization (TVR) rate(1, 6, 9, and 12 months after the operation)
The success rate of intervention treatment: including device success, lesion success and clinical success(1-2 days)
All adverse events and severe adverse events(1, 6, 9, and 12 months after the operation)