Clinical trial NCT03155971: PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
Official title: Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stable Angina Pectoris
Unstable Angina Pectoris
Keywords: Drug-Coated Balloon
Main Coronary Artery
De Novo Lesion
Lead sponsor: The People's Hospital of Liaoning Province
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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）.

Primary outcomes:
measure: QCA late lumen loss
timeFrame: Immediately after the procedure and at 9 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
Study officials:
affiliation: The People's Hospital of Liaoning Province
name: Aijie Hou
role: PRINCIPAL_INVESTIGATOR
References: