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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-02-01

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.

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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.

Conditions

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Stable Angina Pectoris Unstable Angina Pectoris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCB group

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)

Group Type EXPERIMENTAL

Paclitaxel-Coated Balloon

Intervention Type DEVICE

SeQuent ® Please; B.Braun, Melsungen, Germany

Interventions

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Paclitaxel-Coated Balloon

SeQuent ® Please; B.Braun, Melsungen, Germany

Intervention Type DEVICE

Other Intervention Names

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Drug-coated balloon (DCB)

Eligibility Criteria

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Inclusion Criteria

1. 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)；
2. a lesion diameter stenosis \>75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
3. 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.
4. a willingness to receive DCB angioplast or DES implantation.

Exclusion Criteria

1. Patients with acute myocardial infarction within 30 days；
2. a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%；
3. advanced cancer with a life expectancy of \<12 months；
4. Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
5. Pregnant and lactating patients；
6. Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions；
7. Stent restenosis
8. 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°）
9. 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）.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No