Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis

Study 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).

Official Title
-----------------
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)

Conditions
-----------------
Coronary Restenosis

Intervention / Treatment
-----------------
* Device: Drug Eluting Balloon Catheters(RESTORE DEB）
* Device: Drug Eluting Balloon Catheters(SeQuent® Please）


Participation Criteria
=================
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-9. 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. The distance between lesions which require intervention and the target lesions must be >10mm. 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 Patients who had heart transplantation Patients with severe congestive heart failure or NYHA grade IV heart failure Patients with severe valvular heart disease Patients who are unsuitable for the study according to the investigator due to other reasons Related to the diseases: Patients with evidence of extensive thrombosis in the target vessel before intervention Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis) Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery Patients with lesions requiring intervention treatment in 3 vessels The diameter of the branch lesions in the target lesion ≥2.5mm Patients already treated with CABG after in-stent restenosis LM lesions and Ostial lesion within 5mm to the root aorta

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESTORE DEB<br>Conduct Drug Eluting Balloon Catheters(RESTORE DEB） | Device: Drug Eluting Balloon Catheters(RESTORE DEB）<br> <br> |
| Active Comparator: SeQuent® Please<br>Conduct Drug Eluting Balloon Catheters(SeQuent® Please） | Device: Drug Eluting Balloon Catheters(SeQuent® Please）<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late lumen loss of the target lesion |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of intervention treatment: including device success, lesion success and clinical success |  | 1-2 days | 
| 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 | 
| Target lesion failure (TLF) rate |  | 1, 6, 9, and 12 months after the operation | 
| Occurrence rate of major adverse cardiovascular events |  | 1, 6, 9, and 12 months after the operation | 
| All adverse events and severe adverse events |  | 1, 6, 9, and 12 months after the operation |