The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients

Official Title
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To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.

Conditions
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Coronary In Sentrestenosis

Intervention / Treatment
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* Device: paclitaxel-releasing coronary balloon (SeQuent® Please)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria related to subjects At the age of 18-80, Both male and female; Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please） Exclusion Criteria: Criteria related to subjects Women with pregnancy or lactation Patient with cardiac shock Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory Patients with severe valvular heart disease Patients with severe congestive heart failure or NYHA class IV heart failure; Patients who have received heart transplant; Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up. Patients who are currently involved in any other clinical trial; Patients that the investigators think that those are not suitable Criteria related to lesions Chronic total occlusion Lesion that cannot be treated with PTCA or other interventional techniques; The vessel diameter < 2.25 mm Left main disease needed to be treated Exclusion criteria related to concomitant medication Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel. Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: paclitaxel-releasing coronary balloon (SeQuent® Please)|SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure in 12 months after operation | To measure Target Lesion Failure in 12 months by using angiography | 1 year |