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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03155971
Other study ID # CTC-91919
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 15, 2017
Last updated May 15, 2017
Start date July 1, 2017
Est. completion date February 1, 2019

Study information

Verified date May 2017
Source The People's Hospital of Liaoning Province
Contact Fei Xia
Phone +8617702487875
Email xf19870421@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date February 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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).

Study Design


Intervention

Device:
Paclitaxel-Coated Balloon
SeQuent ® Please; B.Braun, Melsungen, Germany

Locations

Country Name City State
China The People's Hospital of Liaoning Province Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
The People's Hospital of Liaoning Province

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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