PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
Primary Purpose
Stable Angina Pectoris, Unstable Angina Pectoris
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paclitaxel-Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Drug-Coated Balloon, Main Coronary Artery, De Novo Lesion
Eligibility Criteria
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).
Sites / Locations
- The People's Hospital of Liaoning Province
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PCB group
Arm Description
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)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03155971
First Posted
May 15, 2017
Last Updated
May 15, 2017
Sponsor
The People's Hospital of Liaoning Province
1. Study Identification
Unique Protocol Identification Number
NCT03155971
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The People's Hospital of Liaoning Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Unstable Angina Pectoris
Keywords
Drug-Coated Balloon, Main Coronary Artery, De Novo Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCB group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Paclitaxel-Coated Balloon
Other Intervention Name(s)
Drug-coated balloon (DCB)
Intervention Description
SeQuent ® Please; B.Braun, Melsungen, Germany
Primary Outcome Measure Information:
Title
QCA late lumen loss
Description
minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)
Time Frame
Immediately after the procedure and at 9 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Xia
Phone
+8617702487875
Email
xf19870421@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhilin Miao
Phone
+8617702487775
Email
miaozl2049@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aijie Hou
Organizational Affiliation
The People's Hospital of Liaoning Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aijie Hou
First Name & Middle Initial & Last Name & Degree
Xizhuang Bai
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
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