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Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paclitaxel-Coated Coronary Balloon Catheters
Paclitaxel-Releasing Coronary Balloon Catheters
Sponsored by
Shanghai Shenqi Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Related to the patients: Age ≥18 and ≤80 years old; Subjects with stable angina, or with unstable angina, or with subacute, old myocardial infarction, or evidence of asymptomatic ischemia; Subjects with left ventricular ejection fraction ≥ 30%; During the study, women of childbearing age should not become pregnant or plan to become pregnant. Therefore, it is recommended that subjects use adequate contraceptive measures until (including) the end of the follow-up period; Subjects should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2. It is required to perform angiography in 9 month; Subjects should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document. Related to the diseases: The target lesion is primary, in situ coronary artery lesion, located on 1 or 2 different coronary vessels, and the number of target lesions on each coronary vessel does not exceed 1; Reference vessel diameter between 2.0 mm and 2.75 mm; Non-target vascular lesions need to be treated with interventional therapy first (must be treated at the same time), after successful treatment, random and target lesions will be treated; Preoperative diameter stenosis must be ≥70% or ≥50% with ischemia; (visual inspection) Each target lesion can only be treated with one experimental drug balloon; Exclusion Criteria: Subjects with myocardial infarction within one week, or subjects whose troponin has not returned to normal despite the onset of myocardial infarction for more than one week; Subjects with severe congestive heart failure or NYHA IV heart failure; Women who are pregnant or breastfeeding; Subjects whose life expectancy does not exceed 1 year or who have factors that make clinical follow-up difficult; Subjects with stroke within 6 months; Subjects who are participating in any other clinical trials and have not reached the primary clinical endpoint; Existing or history of severe liver failure, therefore not eligible for angiography; Existing or history of severe renal failure (GFR<30ml/min), therefore not eligible for angiography; Heart transplant; Cardiogenic shock; Coronary artery spasm without significant stenosis; The researchers think that the subjects are not suitable for others inclusion reason; Evidence of extensive thrombus in the target vessel before intervention; Coronary artery bypass grafting using vein grafts; Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation) Target vessels are distorted or have calcified lesions that cannot be pre-dilated successfully; Lesions within 5 mm from the coronary artery ostia; Lesions that cannot be treated with PTCA or other interventional techniques; After pre-dilation of the target lesion, residual stenosis > 50% or TIMI blood flow < grade 3, and/or type C or above dissection; Subjects with bleeding constitution, contraindicated anticoagulant or antiplatelet drugs; Subjects who cannot tolerate aspirin and/or clopidogrel or have a history of neutropenia or thrombocytopenia, or severe liver insufficiency that prohibits clopidogrel; Subjects who are known to be intolerant or allergic to heparin, contrast medium, paclitaxel, iopromide, polylactic acid-glycolic acid polymer, stainless steel, etc.; Leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000 neutrophils/mm3 for more than 3 days) or history of thrombocytopenia (<100,000 platelets/mm3) subjects; Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months;

Sites / Locations

  • Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel-Coated Coronary Balloon Catheters

Paclitaxel-Releasing Coronary Balloon Catheter

Arm Description

receiving the treatment with Swide®DCB in small vessel cohort

receiving the treatment with SeQuent® please Neo in small vessel cohort

Outcomes

Primary Outcome Measures

In-segment diameter stenosis in target lesion(%).
DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.

Secondary Outcome Measures

Technical success rate
defined as the successful arrival of the device to the target lesion, successful dilation, and smooth withdrawal, without the use of any additional interventional treatment methods, with residual stenosis ≤30% (estimated method), TIMI blood flow grade 3, and no grade C or higher dissection.
Lesion success rate
defined as residual stenosis within the target lesion segment being ≤30% (estimated method) after using any interventional treatment method, with TIMI blood flow grade 3 and no grade C or higher dissection.
Procedural success rate
defined as the absence of device-related composite endpoint events during the hospitalization period on the basis of lesion success rate
The proportion of subjects with target lesion failure.
defined as the composite endpoint of cardiac death, target vessel-related myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR);
The proportion of subjects with patient-related composite endpoints
defined as the composite endpoint of all-cause death, all myocardial infarctions, and any revascularization
Proportion of Subjects' mortality
Proportion of Subjects' myocardial infarction
Proportion of Subjects' target lesion revascularization
Proportion of Subjects' any coronary revascularization
Proportion of Subjects with Thrombotic Events as defined by ARC
includes definite, probable, and unexcluded thrombus in the acute, subacute, late, and late late timeframes
Incidence Rate of All AE and SAE in subjects
Late Lumen Loss
defined as the change in minimal lumen diameter
Incidence of target lesion restenosis
proportion of patients with >50% diameter stenosis

Full Information

First Posted
August 15, 2023
Last Updated
August 31, 2023
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06024525
Brief Title
Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®
Official Title
Prospective, Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Shenqi Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese patients with native coronary heart disease and small vessel lesions(reference diameters from 2.0mm to 2.75 mm) in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent® please Neo
Detailed Description
This study conducted a prospective, multi-center, randomized controlled, non-inferiority clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter (SeQuent® please Neo) in the treatment of coronary artery small vascular disease. A total of 236 participants are planned to be recruited, and they will be allocated into the experimental group and the control group in a 1:1 ratio. All participants will undergo clinical follow-up at 1 month, 6 months, 9 months, 1 year, and 2 years after receiving the drug-eluting balloon angioplasty procedure. Angiographic re-evaluation will be conducted for all participants at 9 months after the procedure. The primary study endpoint will be the in-segment diameter stenosis in target lesion(%) at 9 months postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The use of a third-party independent CEC and an independent coronary angiography core laboratory to adjudicate each primary and other endpoints helps reduce measurement bias from outcome measures.
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel-Coated Coronary Balloon Catheters
Arm Type
Experimental
Arm Description
receiving the treatment with Swide®DCB in small vessel cohort
Arm Title
Paclitaxel-Releasing Coronary Balloon Catheter
Arm Type
Active Comparator
Arm Description
receiving the treatment with SeQuent® please Neo in small vessel cohort
Intervention Type
Device
Intervention Name(s)
Paclitaxel-Coated Coronary Balloon Catheters
Intervention Description
to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
Intervention Type
Device
Intervention Name(s)
Paclitaxel-Releasing Coronary Balloon Catheters
Intervention Description
to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters in SVD patients
Primary Outcome Measure Information:
Title
In-segment diameter stenosis in target lesion(%).
Description
DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
defined as the successful arrival of the device to the target lesion, successful dilation, and smooth withdrawal, without the use of any additional interventional treatment methods, with residual stenosis ≤30% (estimated method), TIMI blood flow grade 3, and no grade C or higher dissection.
Time Frame
Immediate postoperative
Title
Lesion success rate
Description
defined as residual stenosis within the target lesion segment being ≤30% (estimated method) after using any interventional treatment method, with TIMI blood flow grade 3 and no grade C or higher dissection.
Time Frame
Immediate postoperative
Title
Procedural success rate
Description
defined as the absence of device-related composite endpoint events during the hospitalization period on the basis of lesion success rate
Time Frame
during the hospitalization and no more 7 days
Title
The proportion of subjects with target lesion failure.
Description
defined as the composite endpoint of cardiac death, target vessel-related myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR);
Time Frame
in month-1, 6, 9, 12 ,24
Title
The proportion of subjects with patient-related composite endpoints
Description
defined as the composite endpoint of all-cause death, all myocardial infarctions, and any revascularization
Time Frame
in month-1, 6, 9, 12 ,24
Title
Proportion of Subjects' mortality
Time Frame
in month-1, 6, 9, 12 ,24
Title
Proportion of Subjects' myocardial infarction
Time Frame
in month-1, 6, 9, 12 ,24
Title
Proportion of Subjects' target lesion revascularization
Time Frame
in month-1, 6, 9, 12 ,24
Title
Proportion of Subjects' any coronary revascularization
Time Frame
in month-1, 6, 9, 12 ,24
Title
Proportion of Subjects with Thrombotic Events as defined by ARC
Description
includes definite, probable, and unexcluded thrombus in the acute, subacute, late, and late late timeframes
Time Frame
in month-1, 6, 9, 12 ,24
Title
Incidence Rate of All AE and SAE in subjects
Time Frame
in month-1, 6, 9, 12 ,24
Title
Late Lumen Loss
Description
defined as the change in minimal lumen diameter
Time Frame
9 months
Title
Incidence of target lesion restenosis
Description
proportion of patients with >50% diameter stenosis
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Related to the patients: Age ≥18 and ≤80 years old; Subjects with stable angina, or with unstable angina, or with subacute, old myocardial infarction, or evidence of asymptomatic ischemia; Subjects with left ventricular ejection fraction ≥ 30%; During the study, women of childbearing age should not become pregnant or plan to become pregnant. Therefore, it is recommended that subjects use adequate contraceptive measures until (including) the end of the follow-up period; Subjects should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-2. It is required to perform angiography in 9 month; Subjects should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document. Related to the diseases: The target lesion is primary, in situ coronary artery lesion, located on 1 or 2 different coronary vessels, and the number of target lesions on each coronary vessel does not exceed 1; Reference vessel diameter between 2.0 mm and 2.75 mm; Non-target vascular lesions need to be treated with interventional therapy first (must be treated at the same time), after successful treatment, random and target lesions will be treated; Preoperative diameter stenosis must be ≥70% or ≥50% with ischemia; (visual inspection) Each target lesion can only be treated with one experimental drug balloon; Exclusion Criteria: Subjects with myocardial infarction within one week, or subjects whose troponin has not returned to normal despite the onset of myocardial infarction for more than one week; Subjects with severe congestive heart failure or NYHA IV heart failure; Women who are pregnant or breastfeeding; Subjects whose life expectancy does not exceed 1 year or who have factors that make clinical follow-up difficult; Subjects with stroke within 6 months; Subjects who are participating in any other clinical trials and have not reached the primary clinical endpoint; Existing or history of severe liver failure, therefore not eligible for angiography; Existing or history of severe renal failure (GFR<30ml/min), therefore not eligible for angiography; Heart transplant; Cardiogenic shock; Coronary artery spasm without significant stenosis; The researchers think that the subjects are not suitable for others inclusion reason; Evidence of extensive thrombus in the target vessel before intervention; Coronary artery bypass grafting using vein grafts; Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation) Target vessels are distorted or have calcified lesions that cannot be pre-dilated successfully; Lesions within 5 mm from the coronary artery ostia; Lesions that cannot be treated with PTCA or other interventional techniques; After pre-dilation of the target lesion, residual stenosis > 50% or TIMI blood flow < grade 3, and/or type C or above dissection; Subjects with bleeding constitution, contraindicated anticoagulant or antiplatelet drugs; Subjects who cannot tolerate aspirin and/or clopidogrel or have a history of neutropenia or thrombocytopenia, or severe liver insufficiency that prohibits clopidogrel; Subjects who are known to be intolerant or allergic to heparin, contrast medium, paclitaxel, iopromide, polylactic acid-glycolic acid polymer, stainless steel, etc.; Leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000 neutrophils/mm3 for more than 3 days) or history of thrombocytopenia (<100,000 platelets/mm3) subjects; Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chaojun gu
Phone
+86-13636491192
Email
chaojun.gu@sqmedical.com
Facility Information:
Facility Name
Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)
City
Meizhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZHIXIONG ZHONG
Phone
+86 753 213 1363

12. IPD Sharing Statement

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Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

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