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

Stable Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03155971
• Other study ID #: CTC-91919
• 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
• 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).

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Stable Angina Pectoris
• Unstable Angina Pectoris

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