Trial for MicroPort's DCB

Study Overview
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Brief Summary
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This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.

Detailed Description
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This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.

Official Title
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A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Paclitaxel Drug-coated Coronary Artery Balloon Catheter in Patients With Coronary Artery In-stent Restenosis Compared to SeQuent® Please Paclitaxel Drug-coated Coronary Artery Balloon Catheter

Conditions
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Coronary Artery In-stent Restenosis

Intervention / Treatment
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* Device: coronary artery in-stent restenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria: 1.18-75 years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. Angiographic Inclusion Criteria: One or two target lesions; Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm; The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia; There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be >10mm. Exclusion Criteria: General Exclusion Criteria: Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal; Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <30% (ultrasound or left ventricular angiography); The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia; Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; which was judged to be clinically significant by the researchers; Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis; Subjects with bleeding tendency, antiplatelet preparation and anticoagulant treatment contraindications, subjects unable to receive antithrombotic treatment, or subjects unable to tolerate DAPT treatment for three months; Previous history of peptic ulcer or gastrointestinal bleeding within 6 months; Patients with cerebral vascular accident or transient ischemic attack (TIA) within the previous 6 months, or with permanent neurological defects that may lead to non-compliance with the protocol; Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel; The life expectancy of the subjects is less than 12 months; The researcher judged that the subjects had poor compliance and could not complete the study as required;Or for other reasons that the researchers consider inappropriate; Subjects who are participating in any other clinical trial, or who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the main study endpoint; Pregnant or breast-feeding female subjects (women who may be pregnant must undergo a pregnancy test 7 days prior to baseline surgery). Angiographic Exclusion Criteria: In-stent restenosis without successful predilatation; Stent restenosis of vein grafts; Bridge stent restenosis; All three vessels were diseased and needed revascularization; Vessel diameter of branch opening in bifurcation lesions ≥2.5mm; Complete occlusion of blood flow at TIMI level 0 (Mehran type IV stenosis); The lesion was located in the left trunk and within 2mm from the opening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel Drug-coated Balloon<br> | Device: coronary artery in-stent restenosis<br>* treat the petients with coronary artery in-stent restenosis<br>|
| Active Comparator: SeQuent® Please Paclitaxel Drug-coated Balloon<br> | Device: coronary artery in-stent restenosis<br>* treat the petients with coronary artery in-stent restenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment Late Lumen Loss | In-segment Late Lumen Loss | 9 months after coronary angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | defined as residual stenosis ≤30% and TIMI3 blood flow after drug-eluting balloon dilation. | during the procedure | 
| Procedural success | Defined as target lesions with residual stenosis ≤30% and TIMI3 blood flow after any interventional treatment, without thrombus or dissection need interention. | Immediately after the index procedure | 
| Clinical success | Defined as the absence of device-related composite endpoint events during hospitalization (up to 7 days after surgery) on the basis of procedural success. | At time of procedure up to 7 days in hospital | 
| Device-oriented composite endpoints (Target Lesion Failure) | TLF is defined as the composited endpoints of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization. | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| Patient-oriented composite endpoint (PoCE) | Patient-oriented composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization. | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| Death (Cardiac, Non-cardiac) | Defined as death due to the following causes. Acute myocardial infarction; cardiac perforation/cardiac tamponade; arrhythmia or abnormal conduction; death due to surgical complications, including bleeding, vascular repair, transfusion response, or coronary artery bypass surgery; anything that does not rule out death from cardiac causes. Non-cardiac death: defined as death from causes other than the above cardiac causes. | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| The number and rate of Myocardial Infarction (MI) | Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| The number and rate of Target Lesion Revascularization (TLR) | Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| The number and rate of Target Vessel Revascularization (TVR) | Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| The number and rate of Any Revascularization | Ischemia-driven , Not ischemia-driven | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| The number and rate of Thrombosis (per ARC definition) | Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable) | 1 month, 6 months, 9 months, 1 year and 2 years after index procedure | 
| In-segment angiography binary restenosis (ABR, %) | Defined as the proportion of subjects with restenosis occurring in the target lesion segment and the diameter stenosis ≥50%.Quantitative coronary angiography analysis (QCA) calculation (1- 9 months after the operation of the original stent restenosis in-segment residual minimum lumen diameter / reference vessel diameter) ×100% | 9 months after index procedure |