PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)

Study Overview
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Brief Summary
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This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.

Detailed Description
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Paclitaxel-Coated Balloon Catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation. More and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. But there are still seldom evidences in De Novo Lesions of Main Coronary Arteries. PCB has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. The investigators designed this study to evaluate the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.

Official Title
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Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries

Conditions
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Stable Angina Pectoris, Unstable Angina Pectoris

Intervention / Treatment
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* Device: Paclitaxel-Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion（a lesion length of ≥ 20mm)； a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm . a willingness or ability to provide informed consent，a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month. a willingness to receive DCB angioplast or DES implantation. Exclusion Criteria: Patients with acute myocardial infarction within 30 days； a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%； advanced cancer with a life expectancy of <12 months； Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy; Pregnant and lactating patients； Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions； Stent restenosis Thrombotic disease，severe calcified lesions（Judged by the operator， CAG showed class 2 or more severe calcified lesions），spontaneous dissection or ulcerative lesion，coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of RCA or LAD)， severe angulated lesions（>45°） diameter of collateral vessel≥ 2.25 mm requiring interventional therapy,type 1 coronary lesions（Patients with diameter of collateral vessel< 2.25 mm， who were not treated with DCB dilatation were also eligible）.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCB group<br>Prospective, single center, single-group clinical study. Interventions: Patients in the PCB group will be treated (angioplasted) with Paclitaxel-Coated Balloon (SeQuent ® Please; B.Braun, Melsungen, Germany) | Device: Paclitaxel-Coated Balloon<br>* SeQuent ® Please; B.Braun, Melsungen, Germany<br>* Other names: Drug-coated balloon (DCB);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA late lumen loss | minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography) | Immediately after the procedure and at 9 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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De Novo Lesion, Drug-Coated Balloon, Main Coronary Artery